Condition category
Surgery
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
10/12/2007
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 Gilbert Alfred Blaise

ORCID ID

Contact details

Hôpital Notre-Dame du CHUM
Laboratoire d'Anesthésie
Porte FS-1136
1560 rue Sherbrooke Est
Montréal
H2L 4M1
Canada
+1 514-890-8202
blaisegil@sympatico.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-65009

Study information

Scientific title

Acronym

Study hypothesis

To compare two methods of analgesia, optimal perioperative analgesia OPA versus the usual analgesic treatment (UAT), in patients undergoing hand surgery, in terms of postoperative pain control, intensity and duration of the local inflammatory response, impact of pain on function and quality of life.

Trapeziectomy and carpal surgery, bone graph, wrist arthrodesis, distal radial arthrotomy, hand surgery/trauma of hand.

Ethics approval

Ethics approval received from the Comité d'éthique de la recherche, CHUM (Centre Hospitalier de l'Université de Montréal) on the 24th March 2003.

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

Hand surgery

Intervention

Experimental group: non-steroidal anti-inflammatory drug (NSAID) 1 hour before surgery, 1 daily after surgery.
Both groups (OPA and UAT) will receive the same treatment until their admission in the recovery room.

Trial details received: 12 September 2005

Intervention type

Drug

Phase

Not Specified

Drug names

Non-Steroidal Anti-Inflammatory Drugs (NSAID)

Primary outcome measures

Reducing pain intensity at rest and during active movements measured at 8 months.

Secondary outcome measures

1. The impact of pain on Quality of Life (QOL)
2. The impact of pain on activities
3. Inflammation
4. Function

Overall trial start date

01/10/2003

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients, either sex, scheduled for trapeziectomy and carpal surgery:
1. Total and partial carpectomy
2. Bone graph
3. Wrist arthrodesis
4. Distal radial arthrotomy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant exclusion criteria

1. Age under 18 years or older than 75 years
2. Pregnant
3. Allergic to morphine, local anesthetics
4. Suffering from other forms of chronic arthritis or other painful conditions treated chronically (every day) with analgesics (i.e. fibromyalagia)
5. Allergic or intolerant to NSAID (COX2 inhibitors)
6. Consuming anticoagulants which cannot be interrupted
7. Suffering from major cardiovascular problems
8. Suffering from cognitive or psychiatric problems, or drug abuse
9. Other recent hand surgery or axillary surgery with sequels
10. Living alone (no help at home)
11. Unable to understand French or English
12. Without phone access or likely to change address during follow-up

Recruitment start date

01/10/2003

Recruitment end date

30/09/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Hôpital Notre-Dame du CHUM
Montréal
H2L 4M1
Canada

Sponsor information

Organisation

University Hospital of Montreal (CHUM) (Canada)

Sponsor details

Campus Hôtel-Dieu
3840 rue Saint-Urbain
Montréal
H2W 4M1
Canada

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-65009)

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