Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084120704
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the optimal method of pain control after such surgery.
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
Treatment
Patient information sheet
Condition
Surgery: Colorectal
Intervention
Randomised controlled trial comparing
1. Morphine in a drip
2. Morphine in a drip plus ketamine infusion
3. Epidural analgesia in the spine
Currently pain relief is provided by the patient having a button to press to deliver themselves some pain relieving drug. Every hour a nurse will check the patient and observe to make sure the patient is alright and happy with the pain relief. The nurse will ask a few questions on the quality of pain relief. The patient will be asked to do some deep breathing and to cough to aid this assessment.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
The patient will receive one of three pain control regimes:
1. Morphine in a drip
2. Morphine in a drip plus ketamine infusion
3. Epidural analgesia in their back (spine).
The study is to compare the quality and quantity of pain relief, side effects and satisfaction with different drugs and methods of delivery.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
22/03/2002
Overall trial end date
01/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
297 Samples are required. Normal post-operative analgesic requirements with some patients requiring ketamine. Input from pain management team.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
297
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
22/03/2002
Recruitment end date
01/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Surgical Unit
Cottingham, East Yorkshire
HU16 5JQ
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
Research organisation
Funder name
The North and South Bank Research and Development Consortium (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