CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
TAP block using Bupivacaine 0.5% +2 moreprocedure
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/NCT03493828
NCT03493828Phase 3Completed

A Randomized Double Blinded Controlled Trial on the Efficacy of TAP Block in Cesarean Section Patients When Compared to Placebo

New York Presbyterian Brooklyn Methodist Hospital·interventional·Posted Apr 11, 2018·Updated Nov 13, 2018

In Brief

A Phase 3 clinical trial evaluating TAP block using Bupivacaine 0.5%, TAP block using Bupivacaine 0.25%, and 1 other intervention for Pain Control. Completed, enrolled 60 participants across 1 site.

Detailed Summary

TAP Block done with 2 different concentrations of bupivacaine and placebo

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain Control
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 11, 2018
Enrollment StartJun 1, 2013
Primary CompletionOct 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.2 years ago

Interventions

TAP block using Bupivacaine 0.5%procedure

Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.

TAP block using Bupivacaine 0.25%procedure

Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.

TAP block using Normal Salineprocedure

Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.