Trial Outcomes & Findings for Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks (NCT NCT03476642)
NCT ID: NCT03476642
Last Updated: 2025-05-02
Results Overview
A consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
20 minutes from the time of the ESP block
Results posted on
2025-05-02
Participant Flow
Participant milestones
| Measure |
0.5% Ropivacaine With Epinephrine
no adverse events
|
0.5% Ropivacaine Without Epinephrine
No advere events
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Age, Continuous
|
42 years
n=6 Participants
|
31 years
n=6 Participants
|
37 years
n=12 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 20 minutes from the time of the ESP blockA consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Area of Dermatomal Sensory Loss at 20 Min
|
68.8 cm^2
Standard Deviation 43.7
|
167.5 cm^2
Standard Deviation 178.0
|
PRIMARY outcome
Timeframe: 60 minutes from the time of the ESP blockA consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Area of Dermatomal Sensory Loss 60 Min
|
90.2 cm^2
Standard Deviation 43.9
|
61.0 cm^2
Standard Deviation 37.1
|
PRIMARY outcome
Timeframe: 120 minutes from the time of the ESP blockA consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Area of Dermatomal Sensory Loss 120 Min
|
107.1 cm^2
Standard Deviation 69.8
|
109.1 cm^2
Standard Deviation 125.0
|
PRIMARY outcome
Timeframe: 240 minutes from the time of the ESP blockA consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Area of Dermatomal Sensory Loss at 240 Min
|
55.5 cm^2
Standard Deviation 36.0
|
114.5 cm^2
Standard Deviation 170.8
|
PRIMARY outcome
Timeframe: 360 minutes from the time of the ESP blockA consultant anesthesiologist blinded to the randomization allocation will perform a sensory assessment for loss of sensation to cold using ethanol on the skin
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Area of Dermatomal Sensory Loss 360 Min
|
35.0 cm^2
Standard Deviation 46.1
|
12.9 cm^2
Standard Deviation 24.3
|
PRIMARY outcome
Timeframe: These samples will be repeated at 20 minutes after completion of the injection of active drug.3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Venous Plasma Concentration of Ropivacaine at 20 Min
|
599.6 ng/mL
Standard Deviation 187.2
|
1284.7 ng/mL
Standard Deviation 336.5
|
PRIMARY outcome
Timeframe: These samples will be repeated at 60 minutes after completion of the injection of active drug.3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Venous Plasma Concentration of Ropivacaine at 60 Min
|
669.0 ng/mL
Standard Deviation 114.4
|
962.4 ng/mL
Standard Deviation 365.3
|
PRIMARY outcome
Timeframe: These samples will be repeated at 90 minutes after completion of the injection of active drug.3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Venous Plasma Concentration of Ropivacaine at 90 Min
|
625.9 ng/mL
Standard Deviation 171.9
|
837.9 ng/mL
Standard Deviation 349.3
|
PRIMARY outcome
Timeframe: These samples will be repeated at 120 after completion of the injection of active drug.3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Venous Plasma Concentration of Ropivacaine at 120 Min
|
640.0 ng/mL
Standard Deviation 129.5
|
691.6 ng/mL
Standard Deviation 289.9
|
PRIMARY outcome
Timeframe: These samples will be repeated at 240 minutes after completion of the injection of active drug.3 ml of blood will be obtained from the Intravenous line already placed in the subject prior to performing the block.
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Venous Plasma Concentration of Ropivacaine at 240 Min
|
480.3 ng/mL
Standard Deviation 99.0
|
420.9 ng/mL
Standard Deviation 183.5
|
PRIMARY outcome
Timeframe: 30 minutes from the time of the ESP blockThe subject will undergo two MRIs to determine the spread of the anesthetic.
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Volume of Injectate Spread Measured Using MRI at 30 Min
|
4373.2 mm^3
Standard Deviation 1013.5
|
3712.8 mm^3
Standard Deviation 1011.3
|
PRIMARY outcome
Timeframe: 90 minutes from the time of the ESP blockThe subject will undergo two MRIs to determine the spread of the anesthetic.
Outcome measures
| Measure |
0.5% Ropivacaine With Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
|
0.5% Ropivacaine Without Epinephrine
n=6 Participants
20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.
|
|---|---|---|
|
Volume of Injectate Spread Measured Using MRI at 90 Min
|
3863.0 mm^3
Standard Deviation 944.6
|
3751.2 mm^3
Standard Deviation 1197.2
|
Adverse Events
Group With EPI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Without Epi
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
Dr. Sanjib Adhikary
Penn State MS Hershey College of Medicine-PennState Health
Phone: 717-531-6140
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place