Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
01/07/2014
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 Philip Mathew

ORCID ID

Contact details

Anaesthetic Department
Gateshead Health NHS Trust
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
+44 (0)191 403 2046

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0009109897

Study information

Scientific title

Acronym

Study hypothesis

The continuous infusion of bupivacaine intraarticularly will decrease the postoperative morphine requirement following knee arthroplasty surgery.

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

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Signs and Symptoms: Pain

Intervention

60 patients scheduled to undergo primary knee replacement will be divided into two groups of 30 each. All of them will receive spinal anaesthesia for the surgical procedure and at the end of the procedure, a 18 G epidural catheter will be inserted into the joint aseptically. Both the groups will receive a continuous infusion of either 0.25% bupicacaine or normal saline respectively into the joint for 48 h in the postoperative period. All of them will receive morphine PCA postoperatively for analgesia along with non-steroidal anti-inflamatory agents as per protocol. The prospective pain relief, morphine and other analgesic requirements will be assessed. The side effects, if any, will be noted. The results will be analysed statistically.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain score, sedation score, PCA morphine consumption and co-analgesic consumption will be noted postoperatively at regular intervals.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

31/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

The study population will consist of patients admitted by the Department of Orthopaedics, QEH, for unilateral primary knee arthroplasty who are willing to take part in the study

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2001

Recruitment end date

31/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetic Department
Gateshead
NE9 6SX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Gateshead Health 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