Trial Outcomes & Findings for Paracervical Versus Intracervical Lidocaine (NCT NCT00816751)
NCT ID: NCT00816751
Last Updated: 2019-08-13
Results Overview
VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
at completion of procedure
Results posted on
2019-08-13
Participant Flow
Participant milestones
| Measure |
Paracervical Block
Paracervical block: The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.
Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
|
Intracervical Block
Intracervical: The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.
Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
|
Overall Study
COMPLETED
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paracervical Versus Intracervical Lidocaine
Baseline characteristics by cohort
| Measure |
Paracervical Block
n=45 Participants
All patients who met inclusion criteria were approached for the study. Exclusion criteria included gestational age greater than 12 weeks, patient age less than 18, patient weight less than 44 kg, patient allergy to any component of the local anesthetic, patient need for general anesthesia, inability to understand the consent form, nonviable pregnancy, current incarceration.
|
Intracervical Block
n=44 Participants
All patients who met inclusion criteria were approached for the study. Exclusion criteria included gestational age greater than 12 weeks, patient age less than 18, patient weight less than 44 kg, patient allergy to any component of the local anesthetic, patient need for general anesthesia, inability to understand the consent form, nonviable pregnancy, current incarceration.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at completion of procedureVAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain
Outcome measures
| Measure |
Paracervical Block
n=45 Participants
Paracervical block: The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.
Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
|
Intracervical Block
n=44 Participants
Intracervical: The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.
Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
|
|---|---|---|
|
Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)
|
4.25 units on a scale
Standard Deviation 0.6
|
3.97 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: At the time of the procedureOutcome measures
| Measure |
Paracervical Block
n=45 Participants
Paracervical block: The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.
Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
|
Intracervical Block
n=44 Participants
Intracervical: The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.
Buffered Lidocaine, vasopressin, sodium bicarbonate: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
|
|---|---|---|
|
Gestational Age at Time of Procedure
|
51 Days
Standard Deviation 11
|
54 Days
Standard Deviation 9
|
Adverse Events
Paracervical Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intracervical Block
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