CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
TAP Block +1 moredrug
Likely dose
TAP Block 20 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/NCT03532906
NCT03532906N/ACompleted

Is it Feasible to Conduct a Randomised Controlled Trial (RCT) of the Transverse Abdominis Plane (TAP) Block Versus Anaesthetic Injections to the Wound Site for Patients Requiring Laparoscopic Cholecystectomy?

Royal Devon and Exeter NHS Foundation Trust·interventional·Posted May 22, 2018·Updated Apr 28, 2021

In Brief

A clinical study evaluating TAP Block and Control for Postoperative Pain. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The objective of the study is to hopefully understand the most beneficial way to control pain after removing the gallbladder by keyhole surgery (laparoscopic cholecystectomy). The investigators will investigate two groups of patients undergoing laparoscopic cholecystectomy. One group will receive the injection of local anaesthetic into the abdominal wall (TAP block) and into the wounds; the second group will have local anaesthetic into the wounds only. In order to have meaningful results, we anticipate a large number of participants would be required. Therefore we would test first whether it is technically possible to set up the study itself. The investigators will be looking at parameters (willingness of patients to be recruited, willingness of clinicians to recruit participants, number of eligible patients, follow-up rates, adherence/compliance rates, number of participants needed for an adequate sample size) that will allow to understand if such a larger trial is technically possible to set up.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 22, 2018
Enrollment StartJul 1, 2018
Primary CompletionApr 26, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.1 years ago

Interventions

TAP Blockdrug

Injection of Bupivacaine 0.5% 20 ml into the thickness of the right abdominal wall and of Bupivacaine 0.5% 10 ml into the surgical wounds.

Controldrug

Injection of Bupivacaine 0.5% 10 ml into the surgical wounds