Periportal Bupivacaine For Pain Relief After Laparoscopic Cholecysectomy

ISRCTN ISRCTN29748753
DOI https://doi.org/10.1186/ISRCTN29748753
Secondary identifying numbers N0650147577
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
08/04/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr R Anderson
Scientific

Surgical CSG
Ormskirk Dist Gen Hosp
Wigan Road
Ormskirk
L39 2AZ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectives1. Does Pre-incisional injection of bupivacaine decrease postoperative pain following laparoscopic cholecystectomy and allow for early discharge from hospital?
2. To determine any early or late (6 week) related complications.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Post operative pain
InterventionRandomisation of patients to intervention group and control group.
Intervention typeOther
Primary outcome measure1. Pain intensity scored using visual analogue scale at 4, 6 and 24 hrs from the commencement of operation
2. Time to first demand of analgesia
3. Total analgesic requirement in first 24 hrs
4. Assessment of opportunity for same day discharge
5. Assessment of early/late (6 weeks) postoperative complications
6. Scar quality at 6 weeks
Secondary outcome measuresNot provided at time of registration
Overall study start date17/01/2002
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants60
Key inclusion criteria60 patients from waiting lists of two General Surgeons based at Ormskirk District General Hospital (RJL Anderson; NK Matar)
Key exclusion criteriaNot provided at time of registration
Date of first enrolment17/01/2002
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Surgical CSG
Ormskirk
L39 2AZ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Southport and Ormskirk Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan