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

NCT03442036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-02-17

Study results available
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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.

Conditions

  • Regional Anesthesia
  • Sciatic Nerve Block

Interventions

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

DEVICE

Through-the-Needle Technique

Perineural catheters are inserted through a straight hollow-bore needle

Sponsors & Collaborators

Principal Investigators

  • John J Finneran IV, MD · UC San Diego

  • Brian M Ilfeld, MD, MS · UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-06
Primary Completion
2019-04-01
Completion
2019-04-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03442036 on ClinicalTrials.gov