Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0283122688
Study information
Scientific title
Acronym
Study hypothesis
Does the intermittent infiltration of 0.25% bupivacaine delivered by an epidural catheter into the rectus sheath decrease the opioid requirement postoperatively after a midline laparotomy?
Ethics approval
Not provided at time of registration
Study design
Single centre prospective 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: Pain, nausea, vomiting, itching
Intervention
1. 0.25% Bupivacaine
2. Saline
Intervention type
Drug
Phase
Not Specified
Drug names
bupivacaine
Primary outcome measures
The primary outcome measure will be the total amount of opiate used in the intravenous patient controlled analgesia (IVPCA) in the first 48 h.
.
Secondary outcome measures
Secondary outcome measures will be forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) at 24 and 48 h, the number of episodes of nausea, vomiting, itching, the sedation score, and respiratory rate, the time to passage of flatus and the length of hospital stay.
Overall trial start date
20/04/2002
Overall trial end date
20/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
40 consenting patients due to undergo a laparotomy.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
20/04/2002
Recruitment end date
20/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing, West Sussex
BN11 2DH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Commercial educational grant
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