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
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