An investigation to compare analgesia from 0.5 mg or 1 mg of intrathecal diamorphine when undergoing total knee replacement surgery

ISRCTN	ISRCTN28694723
DOI	https://doi.org/10.1186/ISRCTN28694723
Protocol serial number	N0247130747
Sponsor	Department of Health
Funder	Swindon and Marlborough NHS Trust (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

Dr Malcolm Watters
Scientific

The Great Western Hospital
Marlborough Road
Swindon
SN3 6BB
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does a higher dose of diamorphine provide better pain relief with fewer side effects?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Total knee replacement (TKR) surgery analgesia
Intervention	Prior to total knee replacement surgery, patients will be randomised to: 1. 0.5 mg intrathecal diamorphine 2. 1 mg intrathecal diamorphine
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Key inclusion criteria	1. Adult primary total knee replacements 2. Aged 18 - 70 years
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	10/03/2003
Date of final enrolment	31/03/2004

The Great Western Hospital

Swindon
SN3 6BB
United Kingdom

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