Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by:
University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier:
NCT01090882
First received: March 18, 2010
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

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 Intervention
Gall Stones
Drug: Bupivocaine
Drug: 0.9% normal saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial

Further study details as provided by University Hospitals Coventry and Warwickshire NHS Trust:

Primary Outcome Measures:
  • VAS pain score [ Time Frame: 1, 4, 8 hours after operation and at discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to ambulation [ Time Frame: following the procedure ] [ Designated as safety issue: No ]
    The first time the patient gets out of bed and walks following the procedure

  • Same day discharge [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • VRS pain scores [ Time Frame: Every 10 minutes in theatre recovery ] [ Designated as safety issue: No ]
    Immediately following the operation


Enrollment: 128
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control
Sham wash, sham injection
Drug: 0.9% normal saline solution
20ml 0.9% NaCl
Other Name: 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 Name: 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 Name: marcaine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective laparoscopic cholecystectomy
  • 18 years old or over

Exclusion Criteria:

  • Emergency surgery
  • Under 18 year olds
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01090882

Locations
United Kingdom
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
  More Information

No publications provided by University Hospitals Coventry and Warwickshire NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Louise Jones R and D manager, University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT01090882     History of Changes
Other Study ID Numbers: UHCW 1
Study First Received: March 18, 2010
Last Updated: March 22, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
Local anaesthetic
Laparoscopic cholecystectomy
Pain scores
Bupivocaine
Day case surgery

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014