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NCT02662023 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by University of California, San Diego.

Completed
Registry status
Phase 4
Development phase
24
Enrollment target

NCT02662023: Completed Phase 4 study, sponsored by University of California, San Diego.

NCT02662023 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02662023, a Phase 4 study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
Phase 4
Development phase
24 participants
Enrollment target

Study 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.

Primary Outcome

The distance of sensory deficit to cold measured in centimeters along the mid-axillary line. A cold roller is a device that looks like a paint application roller, but the roller itself is metal that can be brought to freezing. It is placed in the mid-axillary line and moved up and down until the sensory deficit to cold is revealed and subsequently measured.

Interventions

  • DRUG Bolus
  • DRUG Basal

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2016-02
Est. Completion 2016-06
Phase Phase 4
University of California, San Diego

775 total trials

What the finished NCT02662023 record still lists

NCT02662023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Bolus is the first listed.

NCT02662023 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02662023 about?

NCT02662023 is a clinical study titled "Continuous TAP Blocks: Relative Effects of a Basal Infusion vs. Repeated Bolus Doses". 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 hou...

What is the current status of trial NCT02662023?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2016-02. Estimated completion is 2016-06.

What interventions are being tested in trial NCT02662023?

The interventions under investigation include: Bolus (DRUG), Basal (DRUG).

Who is sponsoring clinical trial NCT02662023?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02662023's enrollment target sits among peer trials

24 1699th of 2000 higher than 276 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02662023, the US trial registry maintained by the National Library of Medicine. NCT02662023 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.