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| [ Print-friendly version ] |
| Optimal perioperative analgesia in hand surgery |
| ISRCTN | ISRCTN97731480 |
| ClinicalTrials.gov identifier | |
| Public title | Optimal perioperative analgesia in hand surgery |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | MCT-65009 |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Hand surgery |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/10/2003 |
| Anticipated end date | 30/09/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 220 |
| Interventions |
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 |
| Primary outcome measure(s) | Reducing pain intensity at rest and during active movements measured at 8 months. |
| 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 |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-65009) |
| Trial website | |
| Publications | |
| Contact name | Dr Gilbert Alfred Blaise |
| Address |
Hôpital Notre-Dame du CHUM
Laboratoire d'Anesthésie Porte FS-1136 1560 rue Sherbrooke Est |
| City/town | Montréal |
| Zip/Postcode | H2L 4M1 |
| Country | Canada |
| Tel | +1 514-890-8202 |
| Fax | +1 514-412-7520 |
| blaisegil@sympatico.ca | |
| Sponsor | University Hospital of Montreal (CHUM) (Canada) |
| Address |
Campus Hôtel-Dieu
3840 rue Saint-Urbain |
| City/town | Montréal |
| Zip/Postcode | H2W 4M1 |
| Country | Canada |
| Date applied | 26/09/2005 |
| Last edited | 10/12/2007 |
| Date ISRCTN assigned | 26/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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