Trial Outcomes & Findings for VENLID: The Application of a 10%-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults (NCT NCT06354816)
NCT ID: NCT06354816
Last Updated: 2026-04-02
Results Overview
The volunteer is asked to mark her pain level in NRS (Numeric Rating Scale). NRS is a 11 point scale (0-10) where patients rate their pain intensity, with 0 being "no pain" and 10 being "the worst pain" imaginable. This tool is commonly used to measure pain severity, categorizing it as mild (1-3), moderate (4-7) or severe (8-10). To measure pain caused by PIVC (Peripheral Intravenous Catheter) rated by NRS, separately analyzed for placebo and LDA (Lidocaine 10% spray - local anesthetic) treated on the hand: vessel at the dorsum manus and forearm/cubita. In summary, this results in 4 groups (combinations of treatment-location). The NRS values reported in this outcome measure are the same as those reported in Outcome Measure 3. This outcome measure is included separately to present the pre-specified statistical comparisons of Hand - Placebo vs. Hand - LA and Forearm - Placebo vs. Forearm - LA, which differ from those presented in the companion measure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
2 minutes
Results posted on
2026-04-02
Participant Flow
Randomization: It was planned to include 40 healthy female volunteers into this trial. Healthy volunteers were contacted via email.
Participant milestones
| Measure |
A: Dominant/ Saline Solution Isotonic 0.9% NaCl - Non-dominant/Xylocaine 10% Pump Spray
Vessel at the dorsum manus: dominant/ placebo - non-dominant/ LA (Local anaesthesia)
Forearm/cubita: dominant/ placebo - non dominant/ LA (Local anaesthesia)
Xylocaine 10% pump spray: First volunteers will undergo insertion of PIVC into the vessel of dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Lidocaine spray 10 % serves as a local anesthesia is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
Saline solution isotonic 0.9% NaCl: First volunteers will undergo insertion of PIVC into the vessel at dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Physiological saline solution serves as a placebo and is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
|
B: Non-dominant/ Saline Solution Isotonic 0.9% NaCl - Dominant/ Xylocaine 10% Pump Spray
Vessel at the dorsum manus: non-dominant/ placebo - dominant/ LA (Local anaesthesia)
Forearm/cubita: non-dominant/ placebo - dominant/ LA (Local anaesthesia)
Xylocaine 10% pump spray: First volunteers will undergo insertion of PIVC into the vessel of dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Lidocaine spray 10 % serves as a local anesthesia is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
Saline solution isotonic 0.9% NaCl: First volunteers will undergo insertion of PIVC into the vessel at dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Physiological saline solution serves as a placebo and is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
|
C: Non-dominant/ Xylocaine 10% Pump Spray - Dominant/ Saline Solution Isotonic 0.9% NaCl
Vessel at the dorsum manus: non-dominant/ LA (Local anaesthesia)- dominant/ placebo
Forearm/cubita: non-dominant/ LA (Local anaesthesia) - dominant/ placebo
Xylocaine 10% pump spray: First volunteers will undergo insertion of PIVC into the vessel of dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Lidocaine spray 10 % serves as a local anesthesia is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
Saline solution isotonic 0.9% NaCl: First volunteers will undergo insertion of PIVC into the vessel at dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Physiological saline solution serves as a placebo and is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
|
D: Dominant/ Xylocaine 10% Pump Spray - Non-dominant/ Saline Solution Isotonic 0.9% NaCl
Vessel at the dorsum manus: dominant/ LA (Local anaesthesia) - non-dominant/ placebo
Forearm/cubita: dominant/ LA (Local anaesthesia) - non-dominant/ placebo
Xylocaine 10% pump spray: First volunteers will undergo insertion of PIVC into the vessel of dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Lidocaine spray 10 % serves as a local anesthesia is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
Saline solution isotonic 0.9% NaCl: First volunteers will undergo insertion of PIVC into the vessel at dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Physiological saline solution serves as a placebo and is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VENLID: The Application of a 10%-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults
Baseline characteristics by cohort
| Measure |
A: Dominant/ Saline Solution Isotonic 0.9% NaCl - Non-dominant/Xylocaine 10% Pump Spray
n=10 Participants
Vessel at the dorsum manus: dominant/ placebo - non-dominant/ LA (Local anaesthesia)
Forearm/cubita: dominant/ placebo - non dominant/ LA (Local anaesthesia)
Xylocaine 10% pump spray: First volunteers will undergo insertion of PIVC into the vessel of dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Lidocaine spray 10 % serves as a local anesthesia is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
Saline solution isotonic 0.9% NaCl: First volunteers will undergo insertion of PIVC into the vessel at dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Physiological saline solution serves as a placebo and is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
|
B: Non-dominant/ Saline Solution Isotonic 0.9% NaCl - Dominant/ Xylocaine 10% Pump Spray
n=10 Participants
Vessel at the dorsum manus: non-dominant/ placebo - dominant/ LA (Local anaesthesia)
Forearm/cubita: non-dominant/ placebo - dominant/ LA (Local anaesthesia)
Xylocaine 10% pump spray: First volunteers will undergo insertion of PIVC into the vessel of dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Lidocaine spray 10 % serves as a local anesthesia is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
Saline solution isotonic 0.9% NaCl: First volunteers will undergo insertion of PIVC into the vessel at dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Physiological saline solution serves as a placebo and is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
|
C: Non-dominant/ Xylocaine 10% Pump Spray - Dominant/ Saline Solution Isotonic 0.9% NaCl
n=10 Participants
Vessel at the dorsum manus: non-dominant/ LA (Local anaesthesia)- dominant/ placebo
Forearm/cubita: non-dominant/ LA (Local anaesthesia) - dominant/ placebo
Xylocaine 10% pump spray: First volunteers will undergo insertion of PIVC into the vessel of dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Lidocaine spray 10 % serves as a local anesthesia is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
Saline solution isotonic 0.9% NaCl: First volunteers will undergo insertion of PIVC into the vessel at dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Physiological saline solution serves as a placebo and is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
|
D: Dominant/ Xylocaine 10% Pump Spray - Non-dominant/ Saline Solution Isotonic 0.9% NaCl
n=10 Participants
Vessel at the dorsum manus: dominant/ LA (Local anaesthesia) - non-dominant/ placebo
Forearm/cubita: dominant/ LA (Local anaesthesia) - non-dominant/ placebo
Xylocaine 10% pump spray: First volunteers will undergo insertion of PIVC into the vessel of dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Lidocaine spray 10 % serves as a local anesthesia is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
Saline solution isotonic 0.9% NaCl: First volunteers will undergo insertion of PIVC into the vessel at dorsum manus; 2-10 hours later: All volunteers will undergo insertion of PIVC into the forearm/cubita. Physiological saline solution serves as a placebo and is applied with a dispenser dispensing 0.1ml per pulse on the area of the skin, where the insertion of the PIVC is planned.
Exposure time is 2 min, timed with an hour glass; validated prior to the study by a stop watch. 0.5 ml (5 pulses) of 10% lidocaine spray (equals 50mg of lidocaine) are to be applied before insertion of a PIVC 18 Gauge.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=5 Participants
|
40 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=5 Participants
|
40 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=5 Participants
|
40 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 2 minutesPopulation: healthy women volunteers
The volunteer is asked to mark her pain level in NRS (Numeric Rating Scale). NRS is a 11 point scale (0-10) where patients rate their pain intensity, with 0 being "no pain" and 10 being "the worst pain" imaginable. This tool is commonly used to measure pain severity, categorizing it as mild (1-3), moderate (4-7) or severe (8-10). To measure pain caused by PIVC (Peripheral Intravenous Catheter) rated by NRS, separately analyzed for placebo and LDA (Lidocaine 10% spray - local anesthetic) treated on the hand: vessel at the dorsum manus and forearm/cubita. In summary, this results in 4 groups (combinations of treatment-location). The NRS values reported in this outcome measure are the same as those reported in Outcome Measure 3. This outcome measure is included separately to present the pre-specified statistical comparisons of Hand - Placebo vs. Hand - LA and Forearm - Placebo vs. Forearm - LA, which differ from those presented in the companion measure.
Outcome measures
| Measure |
Hand: Vessel at the Dorsum Manus - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus- 10% Lidocaine LA
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Lidocaine 10% LA
n=39 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus - Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with the placebo medication.
|
Hand: Vessel at the Dorsum Manus- Dominant- Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with Lidocaine 10% medication.
|
Forearm/Cubita: Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with the placebo medication.
|
Forearm/Cubita: Dominant - Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with 10% Lidocaine medication.
|
|---|---|---|---|---|---|---|---|---|
|
Pain Difference Caused by PIVC (Peripheral Intravenous Catheter) Rated by NRS (Numeric Rating Scale) Between Application of 10% Licocaine Spray and Placebo-for the Hand/Vessel at the Dorsum Manus and for the Forearm/Cubita.
|
2.00 units on a scale
Interval 1.0 to 3.0
|
1.00 units on a scale
Interval 0.0 to 2.0
|
1.00 units on a scale
Interval 1.0 to 2.0
|
1.00 units on a scale
Interval 0.0 to 1.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 minutesThe volunteer is asked to mark her pain level in NRS (Numeric Rating Scale). NRS is a 11 point scale (0-10) where patients rate their pain intensity, with 0 being "no pain" and 10 being "the worst pain" imaginable. This tool is commonly used to measure pain severity, categorizing it as mild (1-3), moderate (4-7) or severe (8-10). To measure pain caused by PIVC (Peripheral Intravenous Catheter) rated by NRS in the dominant vs. non-dominant arm, separately analyzed for placebo and LDA (Lidocaine 10% spray - local anesthetic) on the hand: vessel at the dorsum manus and forearm/cubita. In summary, this results in 8 groups (combinations of treatment-location-dominance). Comparison of pain caused by PIVC rated by NRS in the dominant vs. non-dominant arm, separately analyzed for placebo/LDA and hand/forearm.
Outcome measures
| Measure |
Hand: Vessel at the Dorsum Manus - Placebo
n=20 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Placebo
n=20 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus- 10% Lidocaine LA
n=20 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Lidocaine 10% LA
n=20 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus - Dominant- Placebo
n=20 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with the placebo medication.
|
Hand: Vessel at the Dorsum Manus- Dominant- Lidocaine 10% Local Anesthetic
n=20 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with Lidocaine 10% medication.
|
Forearm/Cubita: Dominant- Placebo
n=20 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with the placebo medication.
|
Forearm/Cubita: Dominant - Lidocaine 10% Local Anesthetic
n=20 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with 10% Lidocaine medication.
|
|---|---|---|---|---|---|---|---|---|
|
Pain Caused by PIVC (Peripheral Intravenous Catheter) in the Dominant Versus Non-dominant Arm.
|
1.50 units on a scale
Interval 0.5 to 3.0
|
1.50 units on a scale
Interval 1.0 to 2.5
|
1.00 units on a scale
Interval 0.0 to 1.5
|
1.00 units on a scale
Interval 0.0 to 1.0
|
2.00 units on a scale
Interval 1.5 to 3.0
|
1.00 units on a scale
Interval 1.0 to 1.5
|
1.00 units on a scale
Interval 0.5 to 2.0
|
1.00 units on a scale
Interval 0.0 to 1.5
|
SECONDARY outcome
Timeframe: 2 minutesThe volunteer is asked to mark her pain level in NRS . NRS is a 11 point scale (0-10) where patients rate their pain intensity, with 0 being "no pain" and 10 being "the worst pain" imaginable. This tool is commonly used to measure pain severity, categorizing it as mild (1-3), moderate (4-7) or severe (8-10). In summary, this results in 4 groups (combinations of treatment-location). Comparison of pain caused by PIVC rated by NRS between location, separately analyzed for placebo and LDA. The NRS values reported in this outcome measure are the same as those reported in Primary Outcome Measure. This outcome measure is included separately to present the pre-specified statistical comparisons of Hand - Placebo vs. Forearm - Placebo and Hand - LA vs. Forearm - LA, which differ from those presented in the companion measure.
Outcome measures
| Measure |
Hand: Vessel at the Dorsum Manus - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus- 10% Lidocaine LA
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Lidocaine 10% LA
n=39 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus - Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with the placebo medication.
|
Hand: Vessel at the Dorsum Manus- Dominant- Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with Lidocaine 10% medication.
|
Forearm/Cubita: Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with the placebo medication.
|
Forearm/Cubita: Dominant - Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with 10% Lidocaine medication.
|
|---|---|---|---|---|---|---|---|---|
|
Pain Caused by PIVC (Peripheral Intravenous Catheter) at the Hand/Vessel at the Dorsum Manus Versus at the Forearm/Cubita
|
2.00 units on a scale
Interval 1.0 to 3.0
|
1.00 units on a scale
Interval 0.0 to 2.0
|
1.00 units on a scale
Interval 1.0 to 2.0
|
1.00 units on a scale
Interval 0.0 to 1.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 minutesThe Spearman correlation coefficient between pain caused by PIVC rated by NRS (Numeric Rating scale) and the anticipated pain rated by NRS, separately analyzed for placebo and LDA (Lidocaine 10% spray - local anesthetic) on both hand: vessel at the dorsum manus and forearm/cubita. In summary, this results in 4 groups (combinations of treatment-location). Four separate comparisons between experienced and anticipated pain will be reported. The volunteer is asked to mark her pain level in NRS. NRS is a 11 point scale (0-10) where patients rate their pain intensity, with 0 being "no pain" and 10 being "the worst pain" imaginable. This tool is commonly used to measure pain severity, categorizing it as mild (1-3), moderate (4-7) or severe (8-10). The entered data in the data table is the NRS of the anticipated pain.
Outcome measures
| Measure |
Hand: Vessel at the Dorsum Manus - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus- 10% Lidocaine LA
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Lidocaine 10% LA
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus - Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with the placebo medication.
|
Hand: Vessel at the Dorsum Manus- Dominant- Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with Lidocaine 10% medication.
|
Forearm/Cubita: Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with the placebo medication.
|
Forearm/Cubita: Dominant - Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with 10% Lidocaine medication.
|
|---|---|---|---|---|---|---|---|---|
|
Correlation Between Pain Caused by PIVC (Peripheral Intravenous Catheter) and the Anticipated Pain.
|
2 units on a scale
Interval 1.0 to 3.0
|
2 units on a scale
Interval 1.0 to 3.0
|
1 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 minutesSpearman correlation coefficient between pain caused by PIVC rated by NRS (Numeric Rating Scale) and the anticipated difficulty to insert the PIVC rated by the operator by NRS, separately analyzed for placebo and LDA (Lidocaine 10% spray - local anesthetic) on both the hand/vessel at the dorsum manus and the forearm/cubita. In summary, this results in 4 groups (combinations of treatment-location). Four separate comparisons between experienced pain and the anticipated difficulty will be reported. The volunteer is asked to mark her pain level in NRS. NRS is a 11 point scale (0-10) where the patient/operator rates the pain/difficulty, with 0 being "no pain"/"very easy" and 10 being "the worst pain"/"most difficult". The entered data in the data table is the NRS of the rated difficulty.
Outcome measures
| Measure |
Hand: Vessel at the Dorsum Manus - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus- 10% Lidocaine LA
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Lidocaine 10% LA
n=39 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus - Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with the placebo medication.
|
Hand: Vessel at the Dorsum Manus- Dominant- Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with Lidocaine 10% medication.
|
Forearm/Cubita: Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with the placebo medication.
|
Forearm/Cubita: Dominant - Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with 10% Lidocaine medication.
|
|---|---|---|---|---|---|---|---|---|
|
Correlation Between Pain Caused by PIVC (Peripheral Intravenous Catheter) and the Anticipated Difficulty Rated by the Operator to Insert the PIVC.
|
2 units on a scale
Interval 1.0 to 5.0
|
2 units on a scale
Interval 1.0 to 5.0
|
1 units on a scale
Interval 0.0 to 2.0
|
1 units on a scale
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 minutesPopulation: Arm Description: Hand: Vessel at dorsum manus and Forearm/cubita in Placebo and LDA Treatment group
Descriptive statistics comparing pain caused by PIVC rated by NRS (Numeric Rating Scale) of insertion of PIVC. This analysis will be calculated separately for placebo and LDA (Lidocaine 10% spray - local anesthetic) on both the hand/vessel at dorsum manus and the forearm/cubita. A difference between success of insertion of PIVC where 0=failure and 1=success will be made also. In summary, this results in 8 groups (combinations of treatment-location-success) for which the NRS is reported. The volunteer is asked to mark her pain level in NRS. NRS is a 11 point scale (0-10) where patients rate their pain intensity, with 0 being "no pain" and 10 being "the worst pain" imaginable. This tool is commonly used to measure pain severity, categorizing it as mild (1-3), moderate (4-7) or severe (8-10).
Outcome measures
| Measure |
Hand: Vessel at the Dorsum Manus - Placebo
n=38 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Placebo
n=36 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus- 10% Lidocaine LA
n=38 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Lidocaine 10% LA
n=36 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus - Dominant- Placebo
n=2 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with the placebo medication.
|
Hand: Vessel at the Dorsum Manus- Dominant- Lidocaine 10% Local Anesthetic
n=4 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with Lidocaine 10% medication.
|
Forearm/Cubita: Dominant- Placebo
n=2 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with the placebo medication.
|
Forearm/Cubita: Dominant - Lidocaine 10% Local Anesthetic
n=3 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with 10% Lidocaine medication.
|
|---|---|---|---|---|---|---|---|---|
|
Pain Caused by PIVC (Peripheral Intravenous Catheter) Between Success and Failure of Insertion of PIVC.
|
2 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 1.0
|
4.5 score on a scale
Interval 4.0 to 5.0
|
2 score on a scale
Interval 1.5 to 3.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.5
|
SECONDARY outcome
Timeframe: 2 minutesPopulation: The data table shows the same numbers in each group. This is not an incorrect entry, but the actual measured data.
Success rate of the venipuncture by descriptive analysis and McNemar test for comparing success rate between hand and forearm. Success is defined as a successful PIVC (Peripheral Intravenous Catheter) insertion at the hand: vessel at the dorsum manus and the forearm/cubita. The success rate at the hand: vessel at the dorsum manus will be compared to the success rate at the forearm/cubita once for the dominant arm and once for the non-dominant arm. In summary, this results in 4 groups (combinations of dominance-location).
Outcome measures
| Measure |
Hand: Vessel at the Dorsum Manus - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus- 10% Lidocaine LA
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Lidocaine 10% LA
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus - Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with the placebo medication.
|
Hand: Vessel at the Dorsum Manus- Dominant- Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with Lidocaine 10% medication.
|
Forearm/Cubita: Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with the placebo medication.
|
Forearm/Cubita: Dominant - Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with 10% Lidocaine medication.
|
|---|---|---|---|---|---|---|---|---|
|
Success Rate of Venipuncture Between Hand and Forearm.
Successful insertion (success=1)
|
37 Participants
|
37 Participants
|
37 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
|
Success Rate of Venipuncture Between Hand and Forearm.
Failed insertion (success=0)
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 minutesPopulation: As explained above the entered data in the data table for the NRS row is per arm (distinction of location and treatment) and for the PCS row is for all participants, because a group distinction is not sensible. But both are needed for the statistical analysis.
The Spearman correlation coefficient between PCS (Pain Catastrophizing Scale) and pain caused by PIVC rated by NRS, separately for placebo and LDA (Lidocaine 10% spray - local anesthetic) on both the hand and the forearm, will be reported. The volunteer is asked to fill in the PCS. In summary, this results in 4 groups (combinations of treatment-location). PCS is a self-assessment questionnaire. PCS has 13-items (total sum score of 13 items ranging from 0-4; 0= not at all; 1=To a slight degree; 2=To a moderate degree; 3=To a great degree; 4=All the time). The questionnaire is designed to assess the extent to which individuals engage in catastrophic thinking related to pain. Subscale Scores: Rumination: Items 8,9,10,11 (0-16); Magnification: Items 6,7,13 (0-12); Helplessness: Items 1,2,3,4,5,12 (0-24). Higher scores indicate a greater degree of pain catastrophizing. The PCS is measured once per participant, therefore there is no group differentiation.
Outcome measures
| Measure |
Hand: Vessel at the Dorsum Manus - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Placebo
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with the placebo medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus- 10% Lidocaine LA
n=40 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the hand: vessel at the dorsum manus treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Forearm/Cubita - Lidocaine 10% LA
n=39 Participants
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the forearm/cubita treated before with 10% Lidocaine medication. The data is combined for both the dominant and non-dominant arm.
|
Hand: Vessel at the Dorsum Manus - Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with the placebo medication.
|
Hand: Vessel at the Dorsum Manus- Dominant- Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the hand: vessel at the dorsum manus treated before with Lidocaine 10% medication.
|
Forearm/Cubita: Dominant- Placebo
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with the placebo medication.
|
Forearm/Cubita: Dominant - Lidocaine 10% Local Anesthetic
This arm includes measurements of the PIVC (Peripheral Intravenous Catheter) performed on the dominant arm at the forearm/cubita treated before with 10% Lidocaine medication.
|
|---|---|---|---|---|---|---|---|---|
|
Correlation Between Pain Caused by PIVC (Peripheral Intravenous Catheter) Rated by NRS and PCS (Pain Catastrophizing Scale).
NRS
|
2.00 score on a scale
Interval 1.0 to 3.0
|
1.00 score on a scale
Interval 1.0 to 2.0
|
1.00 score on a scale
Interval 0.0 to 2.0
|
1.00 score on a scale
Interval 0.0 to 1.0
|
—
|
—
|
—
|
—
|
|
Correlation Between Pain Caused by PIVC (Peripheral Intravenous Catheter) Rated by NRS and PCS (Pain Catastrophizing Scale).
PCS
|
8 score on a scale
Interval 1.75 to 16.25
|
8 score on a scale
Interval 1.75 to 16.25
|
8 score on a scale
Interval 1.75 to 16.25
|
8 score on a scale
Interval 1.75 to 16.25
|
—
|
—
|
—
|
—
|
Adverse Events
Hand:Vessel at the Dorsum Manus- Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hand:Vessel at the Dorsum Manus- Lidocaine 10% LA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Forearm/Cubita-Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Forearm/Cubita-Lidocaine 10% LA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place