Contact information
Type
Scientific
Primary contact
Mr A R Dixon
ORCID ID
Contact details
Department of Surgery
North Bristol NHS Trust
Frenchay Hospital
Frenchay
Bristol
BS16 1ND
United Kingdom
+44 (0)117 970 1212
anthony.dixon@north-bristol.swest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234126586
Study information
Scientific title
Effects of subfascial infiltration of 0.25% bupivacaine versus N/saline in elective abdominal surgery: a randomised controlled trial.
Acronym
Study hypothesis
The effects of subfascial infiltration of 0.25% bupivacaine versus N/saline in elective abdominal surgery: a randomised controlled trial.
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
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Surgery pain scores.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/05/2003
Overall trial end date
30/10/2003
Reason abandoned
Lack of staff
Eligibility
Participant 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).
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/05/2003
Recruitment end date
30/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Surgery
Bristol
BS16 1ND
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Bristol 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