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Feasibility Study on Pain Control After Laparoscopic Cholecystectomy

NCT03532906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-28

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

TAP Block

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.

DRUG

Control

Injection of Bupivacaine 0.5% 10 ml into the surgical wounds

Sponsors & Collaborators

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Antonio Manzelli, MD, PhD · Royal Devon and Exeter NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2021-04-26
Completion
2021-04-26

Countries

  • United Kingdom

Study Locations

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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 NCT03532906 on ClinicalTrials.gov