CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Suture-Method Technique +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03442036
NCT03442036N/ACompleted

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

University of California, San Diego·interventional·Posted Feb 22, 2018·Updated Feb 17, 2021

In Brief

A clinical study evaluating Suture-Method Technique and Through-the-Needle Technique for Regional Anesthesia and Sciatic Nerve Block. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 22, 2018
Enrollment StartApr 6, 2018
Primary CompletionApr 1, 2019
Study CompletionApr 5, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.4 years ago

Interventions

Suture-Method Techniquedevice

Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve

Through-the-Needle Techniquedevice

Perineural catheters are inserted through a straight hollow-bore needle