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Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

Sponsor
University Hospitals Coventry and Warwickshire NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT01090882
Collaborator
(none)
128
Enrollment
1
Location
3
Arms
3
Duration (Months)
42.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial
Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. VAS pain score [1, 4, 8 hours after operation and at discharge]

    Secondary Outcome Measures

    1. Time to ambulation [following the procedure]

      The first time the patient gets out of bed and walks following the procedure

    2. Same day discharge [24 hours]

    3. VRS pain scores [Every 10 minutes in theatre recovery]

      Immediately following the operation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Elective laparoscopic cholecystectomy

    • 18 years old or over

    Exclusion Criteria:

    • Emergency surgery

    • Under 18 year olds

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UHCW NHS Trust Coventry Warwickshire United Kingdom CV2 2DX

    Sponsors and Collaborators

    • University Hospitals Coventry and Warwickshire NHS Trust

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01090882
    Other Study ID Numbers:
    • UHCW 1
    First Posted:
    Mar 23, 2010
    Last Update Posted:
    Mar 23, 2010
    Last Verified:
    Mar 1, 2010
    Keywords provided by , ,
    Local anaesthetic
    Laparoscopic cholecystectomy
    Pain scores
    Bupivocaine
    Day case surgery
    Additional relevant MeSH terms:
    Gallstones
    Bupivacaine

    Study Results

    No Results Posted as of Mar 23, 2010