NCT01090882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

March 18, 2010

Last Update Submit

June 17, 2024

Conditions

Gall Stones

Keywords

Local anaestheticLaparoscopic cholecystectomyPain scoresBupivocaineDay case surgery

Outcome Measures

Primary Outcomes (1)

  • VAS pain score

    1, 4, 8 hours after operation and at discharge

Secondary Outcomes (3)

  • Time to ambulation

    following the procedure

  • Same day discharge

    24 hours

  • VRS pain scores

    Every 10 minutes in theatre recovery

Study Arms (3)

Control

SHAM COMPARATOR

Sham wash, sham injection

Drug: 0.9% normal saline solution

Subperitoneal injection

EXPERIMENTAL

Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder

Drug: Bupivocaine

Topical LA

ACTIVE COMPARATOR

Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm

Drug: Bupivocaine

Interventions

BupivocaineDRUG

20ml 0.25% at beginning of operation

Also known as: marcaine
Subperitoneal injectionTopical LA
0.9% normal saline solutionDRUG

20ml 0.9% NaCl

Also known as: marcaine
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective laparoscopic cholecystectomy
  • years old or over

You may not qualify if:

  • Emergency surgery
  • Under 18 year olds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHCW NHS Trust

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

Related Publications (1)

  • Roberts KJ, Gilmour J, Pande R, Nightingale P, Tan LC, Khan S. Efficacy of intraperitoneal local anaesthetic techniques during laparoscopic cholecystectomy. Surg Endosc. 2011 Nov;25(11):3698-705. doi: 10.1007/s00464-011-1757-3. Epub 2011 Jun 3.

    PMID: 21638181DERIVED

MeSH Terms

Conditions

Gallstones

Interventions

BupivacaineSaline Solution

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Keith J Roberts, MRCS

    University Hospital Coventry and Warwickshire NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 23, 2010

Study Start

July 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations

GB(1)