Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
01/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Edward Smyth

ORCID ID

Contact details

Academic Surgical Unit
Castle Hill Hospital
Castle Rd
Cottingham
East Yorkshire
HU16 5JQ
United Kingdom
+44 (0)1482 875 875

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes