Optimal perioperative analgesia in hand surgery

ISRCTN	ISRCTN97731480
DOI	https://doi.org/10.1186/ISRCTN97731480
Protocol serial number	MCT-65009
Sponsor	University Hospital of Montreal (CHUM) (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-65009)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Gilbert Alfred Blaise
Scientific

Hôpital Notre-Dame du CHUM
Laboratoire d'Anesthésie
Porte FS-1136
1560 rue Sherbrooke Est
Montréal
H2L 4M1
Canada

Phone	+1 514-890-8202
Email	blaisegil@sympatico.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the Comité d'éthique de la recherche, CHUM (Centre Hospitalier de l'Université de Montréal) on the 24th March 2003.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Non-Steroidal Anti-Inflammatory Drugs (NSAID)
Primary outcome measure(s)	Reducing pain intensity at rest and during active movements measured at 8 months.
Key secondary outcome measure(s)	1. The impact of pain on Quality of Life (QOL) 2. The impact of pain on activities 3. Inflammation 4. Function
Completion date	30/09/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	220
Key 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
Key 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
Date of first enrolment	01/10/2003
Date of final enrolment	30/09/2006

Hôpital Notre-Dame du CHUM

Montréal
H2L 4M1
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan