Effects of subfascial infiltration of 0.25% bupivacaine versus N/saline in elective abdominal surgery: a randomised controlled trial.

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 A R Dixon
Scientific

Department of Surgery
North Bristol NHS Trust
Frenchay Hospital
Frenchay
Bristol
BS16 1ND
United Kingdom

Phone	+44 (0)117 970 1212
Email	anthony.dixon@north-bristol.swest.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effects of subfascial infiltration of 0.25% bupivacaine versus N/saline in elective abdominal surgery: a randomised controlled trial.
Study objectives	The effects of subfascial infiltration of 0.25% bupivacaine versus N/saline in elective abdominal surgery: a randomised controlled trial.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Post-operative pain
Intervention	Patients will undergo a simple non-invasive pulmonary function test carried out at the patients bedside and repeated each morning for the first 7 days postoperatively. Added August 2008: trial stopped.
Intervention type	Other
Primary outcome measure(s)	Surgery pain scores.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/10/2003
Reason abandoned (if study stopped)	Lack of staff

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Upper age limit	90 Years
Sex	Not Specified
Target sample size at registration	80
Key inclusion criteria	All patients who require abdominal surgery (midline laparotomy) and are aged between 18-90 will be entered into the study excluding the following: History of drug abuse, chronic pain, regular medication with opioids/non-steroidal anti-inflammatory drugs (NSAIDs), diabetes, morbid obesity, unable to use patient controlled analgesia (PCA). A total of 80 patients will be studied, 40 in each group (those receiving a placebo, and those receiving 0.25% bupivacaine).
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	30/05/2003
Date of final enrolment	30/10/2003

Department of Surgery

Bristol
BS16 1ND
United Kingdom

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