Periportal Bupivacaine For Pain Relief After Laparoscopic Cholecysectomy

ISRCTN	ISRCTN29748753
DOI	https://doi.org/10.1186/ISRCTN29748753
Protocol serial number	N0650147577
Sponsor	Department of Health
Funder	Southport and Ormskirk Hospital NHS Trust (UK)

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

Mr R Anderson
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Post operative pain
Intervention	Randomisation of patients to intervention group and control group.
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	60 patients from waiting lists of two General Surgeons based at Ormskirk District General Hospital (RJL Anderson; NK Matar)
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	17/01/2002
Date of final enrolment	31/12/2006

Surgical CSG

Ormskirk
L39 2AZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan