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Comparing Through-the-Needle With Suture-Method Catheter Designs for Popliteal Nerve Blocks

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ClinicalTrials.gov Identifier: NCT03442036
Recruitment Status : Completed
First Posted : February 22, 2018
Results First Posted : February 10, 2020
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
Ferrosan Medical Devices, Roskilde, Denmark
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Regional Anesthesia
Sciatic Nerve Block
Interventions Device: Suture-Method Technique
Device: Through-the-Needle Technique
Enrollment 70
Recruitment Details Subjects undergoing painful foot/ankle surgery at UCSD were recruited to the study. Total enrollment = 70 subjects.
Pre-assignment Details  
Arm/Group Title Through-the-Needle Technique Suture-Method Technique
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 35 35
Completed 35 35
Not Completed 0 0
Arm/Group Title Through-the-Needle Technique Suture-Method Technique Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
 100.0%
26
  74.3%
61
  87.1%
>=65 years
0
   0.0%
9
  25.7%
9
  12.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
37.5  (12.6) 52.6  (16.8) 45  (16.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
14
  40.0%
14
  40.0%
28
  40.0%
Male
21
  60.0%
21
  60.0%
42
  60.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 35 participants 70 participants
35 35 70
1.Primary Outcome
Title Average Pain Level on Numeric Rating Scale With 0 = no Pain and 10 = Worst Imaginable Pain (Units on a Scale)
Hide Description Surgical pain will be noninferior within the first 2 days following foot/ankle surgery with a suture-method compared with a through-the-needle perineural catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (the mean "average" pain measured daily with a Numeric Rating Scale).
Time Frame first two postoperative days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Through-the-Needle Technique Suture-Method Technique
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: Pain (NRS)
3.4  (2.4) 2.7  (2.4)
2.Secondary Outcome
Title Catheter Dislodgment.
Hide Description We 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.
Time Frame first two postoperative days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Through-the-Needle Technique Suture-Method Technique
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 35 35
Measure Type: Count of Participants
Unit of Measure: Participants
3
   8.6%
0
   0.0%
3.Secondary Outcome
Title Opioid Consumption
Hide Description Opioid consumption will be noninferior within the first 2 days following foot/ankle surgery with a suture-method compared with a through-the-needle perineural catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (cumulative dose).
Time Frame first two postoperative days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Through-the-Needle Technique Suture-Method Technique
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 35 35
Mean (Inter-Quartile Range)
Unit of Measure: mg Oxycodone
25
(5 to 45)
15
(0 to 35)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Through-the-Needle Technique Suture-Catheter
Hide Arm/Group Description 19 Gauge Perineural catheter inserted via a 17 Gauge Touhy Neede 19 Gauge Perineural catheter via 19 G Suture needle
All-Cause Mortality
Through-the-Needle Technique Suture-Catheter
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)      0/35 (0.00%)    
Hide Serious Adverse Events
Through-the-Needle Technique Suture-Catheter
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      1/35 (2.86%)    
Vascular disorders     
Deep vein thrombosis *  0/35 (0.00%)  1/35 (2.86%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Through-the-Needle Technique Suture-Catheter
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/35 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John J. Finneran IV, MD
Organization: University of California San Diego
Phone: 4083073004
EMail: jfinneran@ucsd.edu
Layout table for additonal information
Responsible Party: Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03442036    
Other Study ID Numbers: Suture vs Standard Catheters
First Submitted: February 15, 2018
First Posted: February 22, 2018
Results First Submitted: January 12, 2020
Results First Posted: February 10, 2020
Last Update Posted: March 12, 2020