Continuous TAP Blocks: Relative Effects of a Basal Infusion vs. Repeated Bolus Doses

NCT02662023 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-03-18

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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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Bolus

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.

DRUG

Basal

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.

Sponsors & Collaborators

Principal Investigators

  • Brian Ilfeld, MD, MS · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT02662023 on ClinicalTrials.gov