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
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