Optimal perioperative analgesia in hand surgery
| ISRCTN | ISRCTN97731480 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97731480 |
| Secondary identifying numbers | MCT-65009 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 10/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Contact information
Dr Gilbert Alfred Blaise
Scientific
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 |
|---|---|
| blaisegil@sympatico.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Non-Steroidal Anti-Inflammatory Drugs (NSAID) |
| Primary outcome measure | 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 study start date | 01/10/2003 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Canada
Study participating centre
Hôpital Notre-Dame du CHUM
Montréal
H2L 4M1
Canada
H2L 4M1
Canada
Sponsor information
University Hospital of Montreal (CHUM) (Canada)
University/education
University/education
Campus Hôtel-Dieu
3840 rue Saint-Urbain
Montréal
H2W 4M1
Canada
"ROR" |
https://ror.org/0410a8y51 |
|---|
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-65009)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
