Comparision of epidural versus parental analgesia after colorectal surgery

ISRCTN	ISRCTN48277388
DOI	https://doi.org/10.1186/ISRCTN48277388
Protocol serial number	N0084120704
Sponsor	Department of Health (UK)
Funder	The North and South Bank Research and Development Consortium (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 Edward Smyth
Scientific

Academic Surgical Unit
Castle Hill Hospital
Castle Rd
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom

Phone	+44 (0)1482 875 875

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To evaluate the optimal method of pain control after such surgery.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	297
Key inclusion criteria	297 Samples are required. Normal post-operative analgesic requirements with some patients requiring ketamine. Input from pain management team.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	22/03/2002
Date of final enrolment	01/12/2004

Academic Surgical Unit

Cottingham, East Yorkshire
HU16 5JQ
United Kingdom

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