Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
06/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Malcolm Watters

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0247130747

Study information

Scientific title

Acronym

Study hypothesis

Does a higher dose of diamorphine provide better pain relief with fewer side effects?

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/03/2003

Overall trial end date

31/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult primary total knee replacements
2. Aged 18 - 70 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/03/2003

Recruitment end date

31/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Great Western Hospital
Swindon
SN3 6BB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Swindon and Marlborough 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