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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
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Ferrosan Medical Devices, Roskilde, Denmark
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:
Following painful surgical procedures, postoperative analgesia is often provided with a single-injection peripheral nerve block. Hothe investigatorsver, even with the longest-acting FDA-approved local anesthetic currently available-bupivacaine-the block duration is measured in hours, while the surgical pain may persist for days. A continuous peripheral nerve block allows a prolonged block, consisting of a percutaneously-inserted catheter with its orifice adjacent to a target nerve/plexus through which local anesthetic may be administered. Two basic perineural catheter designs currently exist: (1) catheters that are inserted either through or over a straight hollow-bore needle; and, (2) catheters that are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve ("suture-method" design). To date, a comparison of the relative risks and benefits of these two designs have not been investigated. The investigators therefore propose a randomized, observer-masked, controlled, parallel-arm, clinical trial to compare these two catheter designs when used to provide post-surgical analgesia following foot and ankle surgery.

Condition or disease Intervention/treatment Phase
Regional Anesthesia Sciatic Nerve Block Device: Suture-Method Technique Device: Through-the-Needle Technique Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized using a computer-generated list and opaque, sealed envelopes to one of two treatment groups (blocks of 4, no stratification): perineural catheter insert using (1) through-the-needle technique or (2) suture technique.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Observer-Masked, Controlled, Parallel-Arm, Clinical Trial Comparing Through-the-Needle With Suture-Method Perineural Catheter Designs for Continuous Popliteal-Sciatic Nerve Blocks
Actual Study Start Date : April 6, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 5, 2019

Arm Intervention/treatment
Active Comparator: Through-the-Needle Technique

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.

Device: Through-the-Needle Technique
Perineural catheters are inserted through a straight hollow-bore needle

Experimental: 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 will then be used to infuse local anesthetic directly onto the nerve to provide postoperative pain control.

Device: 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




Primary Outcome Measures :
  1. Average pain level (NRS) [ Time Frame: first two postoperative days ]
    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).


Secondary Outcome Measures :
  1. Catheter dislodgment. [ Time Frame: first two postoperative days ]
    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.

  2. Opioid Consumption [ Time Frame: first two postoperative days ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing ambulatory foot or ankle surgery with a popliteal perineural catheter for postoperative analgesia.

Exclusion Criteria:

  • Pregnancy
  • Inability to communicate with research staff
  • Incarceration
  • Clinically apparent neuropathy in the operative extremity
  • Chronic high dose opioid use
  • History of opioid abuse
  • Concurrent surgery outside the block distribution
  • Patients with nerves deeper than 5 cm from the skin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442036


Locations
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United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Ferrosan Medical Devices, Roskilde, Denmark
Investigators
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Study Director: John J Finneran IV, MD UC San Diego
Principal Investigator: Brian M Ilfeld, MD, MS UC San Diego

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Responsible Party: Brian M. Ilfeld, MD, MS, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03442036     History of Changes
Other Study ID Numbers: Suture vs Standard Catheters
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
Regional Anesthesia
Sciatic Nerve Block
Continuous Nerve Block
Perineural Catheter