Trial Outcomes & Findings for Comparing Through-the-Needle With Suture-Method Catheter Designs for Popliteal Nerve Blocks (NCT NCT03442036)
NCT ID: NCT03442036
Last Updated: 2021-02-17
Results Overview
Pain evaluated using a numeric rating scale with 0 = no pain and 10 = worst imaginable pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
first two postoperative days combined
Results posted on
2021-02-17
Participant Flow
Subjects undergoing painful foot/ankle surgery at UCSD were recruited to the study. Total enrollment = 70 subjects.
Participant milestones
| Measure |
Through-the-Needle Technique
Perineural catheters were inserted through a straight hollow-bore needle.
The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
|
Suture-Method Technique
Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.
The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
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 |
Through-the-Needle Technique
n=35 Participants
Perineural catheters are inserted through a straight hollow-bore needle.
The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
Through-the-Needle Technique: Perineural catheters are inserted through a straight hollow-bore needle
|
Suture-Method Technique
n=35 Participants
Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.
The perineural catheter will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
Suture-Method Technique: Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=70 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=35 Participants
|
26 Participants
n=35 Participants
|
61 Participants
n=70 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=35 Participants
|
9 Participants
n=35 Participants
|
9 Participants
n=70 Participants
|
|
Age, Continuous
|
37.5 Years
STANDARD_DEVIATION 12.6 • n=35 Participants
|
52.6 Years
STANDARD_DEVIATION 16.8 • n=35 Participants
|
45 Years
STANDARD_DEVIATION 16.5 • n=70 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=35 Participants
|
14 Participants
n=35 Participants
|
28 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=35 Participants
|
21 Participants
n=35 Participants
|
42 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
35 participants
n=35 Participants
|
70 participants
n=70 Participants
|
PRIMARY outcome
Timeframe: first two postoperative days combinedPain evaluated using a numeric rating scale with 0 = no pain and 10 = worst imaginable pain
Outcome measures
| Measure |
Through-the-Needle Technique
n=35 Participants
Perineural catheters were inserted through a straight hollow-bore needle.
The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
|
Suture-Method Technique
n=35 Participants
Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.
The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
|
|---|---|---|
|
Average Pain
|
2.7 score on a scale
Standard Deviation 2.4
|
3.4 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: first two postoperative daysCumulative opioid consumption (oxycodone) measured in milligrams
Outcome measures
| Measure |
Through-the-Needle Technique
n=35 Participants
Perineural catheters were inserted through a straight hollow-bore needle.
The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
|
Suture-Method Technique
n=35 Participants
Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.
The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
|
|---|---|---|
|
Opioid Consumption
Postoperative Day 1
|
5.0 milligrams
Interval 0.0 to 15.0
|
10 milligrams
Interval 0.0 to 20.0
|
|
Opioid Consumption
Postoperative Day 2
|
10 milligrams
Interval 0.0 to 20.0
|
10 milligrams
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: Postoperative Days 1 and 2The worst pain score for the day evaluated using a numeric rating scale with 0 = no pain and 10 = worst imaginable pain
Outcome measures
| Measure |
Through-the-Needle Technique
n=35 Participants
Perineural catheters were inserted through a straight hollow-bore needle.
The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
|
Suture-Method Technique
n=35 Participants
Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.
The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
|
|---|---|---|
|
Worst Pain
Postoperative Day 1
|
5.4 score on a scale
Standard Deviation 3.8
|
5.8 score on a scale
Standard Deviation 3.4
|
|
Worst Pain
Postoperative Day 2
|
5.6 score on a scale
Standard Deviation 2.9
|
5.6 score on a scale
Standard Deviation 3.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: first two postoperative daysWe will also test for noninferiority of the suture method to the through-the-needle perineural catheter on gross catheter dislodgment using a 1-tailed noninferiority test.
Outcome measures
| Measure |
Through-the-Needle Technique
n=35 Participants
Perineural catheters were inserted through a straight hollow-bore needle.
The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
|
Suture-Method Technique
n=35 Participants
Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve.
The perineural catheter was then used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.
|
|---|---|---|
|
Catheter Dislodgment.
|
3 Participants
|
0 Participants
|
Adverse Events
Through-the-Needle Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Suture-Catheter
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Through-the-Needle Technique
n=35 participants at risk
19 Gauge Perineural catheter inserted via a 17 Gauge Touhy Neede
|
Suture-Catheter
n=35 participants at risk
19 Gauge Perineural catheter via 19 G Suture needle
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/35 • 1 year
|
2.9%
1/35 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
John J. Finneran IV, MD
University of California San Diego
Phone: 4083073004
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place