CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Bolus +1 moredrug
Likely dose
Bolus 24 mLfrom 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/NCT02662023
NCT02662023Phase 4Completed

Continuous Transversus Abdominis Plane Nerve Blocks: Relative Effects of a Basal Infusion vs. Repeated Bolus Doses (A Randomized, Double-Masked, Active-Control, Split-Body, Crossover Study)

University of California, San Diego·interventional·Posted Jan 25, 2016·Updated Mar 18, 2021

In Brief

A Phase 4 clinical trial evaluating Bolus and Basal for Postoperative Pain. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Single-injection transversus abdominis plane (TAP) blocks have been used to treat postoperative pain, and are become very popular within the United States because of their high analgesic potency and relative ease of placement. Unfortunately, the longest local anesthetic available lasts only 8-12 hours. Continuous TAP blocks-also termed "perineural infusion"-involve bathing the multiple nerves of the abdominal wall in local anesthetic using a percutaneously-inserted perineural catheter inserted just anterior (ventral) and cephalad to the anterior superior iliac spine. For most catheter locations, an infusion is preferred to a single-injection nerve block because the duration of analgesia may be extended to better match the duration of surgical pain. But, unlike brachial plexus, femoral, and sciatic nerve perineural infusion, a continuous basal infusion of local anesthetic does not provide adequate analgesia for TAP catheters. This may be due to the fact that the TAP is a relatively tight space, so it might require a bolus of fluid to adequately spread the perineural local anesthetic to the multiple required nerves (as evidence of this, single-injection TAP blocks are very effective, although with a limited duration). The result is that while single-injection TAP blocks are widely used, TAP catheters have not been adopted. This scenario leaves surgical pain untreated following the resolution of the single-injection TAP block. The recent development of an infusion pump that can automatically deliver repeated bolus doses may allow the spread of local anesthetic to the multiple sensory nerves necessary to provide adequate analgesia, with a duration that better matches postoperative requirements. The investigators therefore propose a randomized, double-masked, controlled trial to determine if delivering local anesthetic as a repeated bolus dose results in improved local anesthetic spread/effects compared with a continuous basal infusion for TAP catheters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsZyno Medical, Teleflex

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 25, 2016
Enrollment StartFeb 1, 2016
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.4 years ago

Interventions

Bolusdrug

A transversus abdominis catheter was inserted and ropivacaine 0.2% administered as two separate bolus doses of 24 mL each: one at time point zero and one 3 hours later.

Basaldrug

A transversus abdominis catheter was inserted and ropivacaine 0.2% administered as a continuous basal infusion (8 mL/h) from time point zero for the following 6 hours.