Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
28/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Clare Hammell

ORCID ID

Contact details

North Cheshire Hospitals NHS Trust
Warrington Hospital
Lovely Lane
Warrington
WA5 1QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0015187634

Study information

Scientific title

A comparison of intrathecal diamorphine and intravenous morphine for postoperative analgesia in patients undergoing lumbar spinal surgery

Acronym

Study hypothesis

Is intrathecal diamorphine injection an effective method for postoperative analgesia in patients following lumbar spinal surgery?

Updated 28/08/2015: The trial was never started due to lack of suitable participants.

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Analgesia

Intervention

Intrathecal diamorphine vs intravenous morphine

Intervention type

Drug

Phase

Not Applicable

Drug names

Diamorphine, morphine

Primary outcome measures

The quality of postoperative analgesia. Patients pain scores will be measured in recovery and on days 1 and 2 postoperatively using a validated pain assessment tool (visual analogue scale 0-100mm). The assessor will be blinded to the patients treatment group. The amounts of morphine required to achieve adequate analgesia via a PCA system will be recorded in both groups.

Secondary outcome measures

Secondary outcome measures include the presence of nausea, vomiting, sedation and pruritis.

Overall trial start date

01/01/2006

Overall trial end date

01/04/2007

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

All ASA 1,2 and 3 patients between the ages of 18 to 70 years undergoing lumbar spinal surgery via a posterior surgical approach will be invited to participate in the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70-80 patients

Participant exclusion criteria

1. Any contraindications to spinal injection (localised skin sepsis at proposed site of injection, coagulopathy)
2. History of allergy to any of the drugs used in the study
3. Severe hepatic or renal disease

Recruitment start date

01/01/2006

Recruitment end date

01/04/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Cheshire Hospitals NHS Trust
Warrington
WA5 1QG
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

North Cheshire Hospitals 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

Publication citations

Additional files

Editorial Notes