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

ISRCTN	ISRCTN01558905
DOI	https://doi.org/10.1186/ISRCTN01558905
Secondary identifying numbers	N0015187634

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 28/08/2015

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

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

Contact information

Dr Clare Hammell
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A comparison of intrathecal diamorphine and intravenous morphine for postoperative analgesia in patients undergoing lumbar spinal surgery
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Analgesia
Intervention	Intrathecal diamorphine vs intravenous morphine
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Diamorphine, morphine
Primary outcome measure	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 study start date	01/01/2006
Completion date	01/04/2007
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	Both
Target number of participants	70-80 patients
Key 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.
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	01/04/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

North Cheshire Hospitals NHS Trust

Warrington
WA5 1QG
United Kingdom

Sponsor information

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

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North Cheshire Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan