Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0650147577
Study information
Scientific title
Acronym
Study hypothesis
1. 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Signs and Symptoms: Post operative pain
Intervention
Randomisation of patients to intervention group and control group.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. 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 measures
Not provided at time of registration
Overall trial start date
17/01/2002
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
60 patients from waiting lists of two General Surgeons based at Ormskirk District General Hospital (RJL Anderson; NK Matar)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
17/01/2002
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Surgical CSG
Ormskirk
L39 2AZ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Southport and Ormskirk Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary