CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 enrolled
Drug / intervention
0.5% ropivacaine +2 moredrug
Likely dose
0.5% ropivacaine 20mlfrom 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/NCT02571439
NCT02571439Phase 4Completed

A Randomized Controlled Trial of Surgical TAP-block After Cesarean Delivery: a Cost-effective Alternative to the Conventional TAP-block

Maimonides Medical Center·interventional·Posted Oct 8, 2015·Updated Aug 3, 2018

In Brief

A Phase 4 clinical trial evaluating Surgical TAP block, Conventional TAP block, and 1 other intervention for POSTOPERATIVE PAIN. Completed, enrolled 41 participants across 1 site.

Detailed Summary

The TAP is a space between the muscle layers of the abdominal wall that houses nerves supplying the abdominal skin. Injecting the local anesthetic ropivacaine into this space will block these nerves and prevent pain following c-section. The investigators will compare two different approaches to injecting the local anesthetic in this space. Conventionally, the block is done after surgery is completed and the abdomen is closed. The anesthesiologist introduces a needle through the abdominal wall skin under ultrasound guidance to reach the TAP space and the drug is injected. Since the TAP layer is one of the deeper layers of the abdominal (belly) wall and is closer to the inside of the abdomen than to the outside (skin), injecting from the inner aspect of the abdominal wall during the surgery is easier and quicker to perform than the conventional block and does not require ultrasound guidance as there is no risk of injury to abdominal organs like the liver. With this research the investigators attempt to prove that surgically administered TAP blocks take 25% less time to perform compared to the conventionally administered TAP block for post cesarean section pain relief. Surgical TAP blocks are also more cost-effective as in addition to reduced OR time, they are safer and do not require skilled operator and specialized equipment. Secondary outcomes will include total time spent in the Operating room, presence and severity of postoperative pain, time to first request for pain medication, total postoperative narcotic consumption in 48 hours after surgery and side effects.

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 8, 2015
Enrollment StartOct 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.7 years ago

Interventions

Surgical TAP blockprocedure

surgeon administered TAP block

Conventional TAP blockprocedure

Anesthesiologist administered TAP block

0.5% ropivacainedrug

20ml of 0.5% ropivacaine is used to perform the TAP block