|
ISRCTN
|
ISRCTN28694723
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
An investigation to compare analgesia from 0.5 mg or 1 mg of intrathecal diamorphine when undergoing total knee replacement surgery
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0247130747
|
|
Study hypothesis
|
Does a higher dose of diamorphine provide better pain relief with fewer side effects?
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Total knee replacement (TKR) surgery analgesia
|
|
Participants - inclusion criteria
|
1. Adult primary total knee replacements
2. Aged 18 - 70 years
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
10/03/2003
|
|
Anticipated end date
|
31/03/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
Prior to total knee replacement surgery, patients will be randomised to:
1. 0.5 mg intrathecal diamorphine
2. 1 mg intrathecal diamorphine
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Swindon and Marlborough NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Malcolm
Watters
|
|
Address
|
The Great Western Hospital
Marlborough Road
|
|
City/town
|
Swindon
|
|
Zip/Postcode
|
SN3 6BB
|
|
Country
|
United Kingdom
|
|
Email
|
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
|
|
Address
|
The Department of Health,
Richmond House,
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2004
|
|
Last edited
|
25/10/2011
|
|
Date ISRCTN assigned
|
30/09/2004
|
