Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

March 22, 2010 updated by: University Hospitals Coventry and Warwickshire NHS Trust

Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial

Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash.

Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV2 2DX
        • UHCW NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective laparoscopic cholecystectomy
  • 18 years old or over

Exclusion Criteria:

  • Emergency surgery
  • Under 18 year olds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Sham wash, sham injection
Drug: 0.9% normal saline solution
20ml 0.9% NaCl
Other Names:
  • marcaine
Experimental: Subperitoneal injection
Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder
Drug: Bupivocaine
20ml 0.25% at beginning of operation
Other Names:
  • marcaine
Active Comparator: Topical LA
Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm
Drug: Bupivocaine
20ml 0.25% at beginning of operation
Other Names:
  • marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS pain score
Time Frame: 1, 4, 8 hours after operation and at discharge
1, 4, 8 hours after operation and at discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to ambulation
Time Frame: following the procedure
The first time the patient gets out of bed and walks following the procedure
following the procedure
Same day discharge
Time Frame: 24 hours
24 hours
VRS pain scores
Time Frame: Every 10 minutes in theatre recovery
Immediately following the operation
Every 10 minutes in theatre recovery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Investigators

  • Principal Investigator: Keith J Roberts, MRCS, University Hospital Coventry and Warwickshire NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 23, 2010

Study Record Updates

Last Update Posted (Estimate)

March 23, 2010

Last Update Submitted That Met QC Criteria

March 22, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCW 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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