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| Sponsor: | Karolinska Institutet |
|---|---|
| Information provided by: | Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00733421 |
Purpose
The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of debate since long.
There is, however, limited data in humans and further prospective randomised studies are warranted. Ekman et al studied in a prospective randomised double blind study the effects of celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery. They found significant effects on reduction of pain and need for opioid analgesics postoperatively but could see no negative effects the numbers of "none-unions" at a 1-year follow up 3.
In a similar prospective randomised double-blind study design significant effects in reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative effects could bee seen on six month follow-up of the strength of the reconstructed ligament.
The aim of the present study is to further study the effects of the perioperative use of etoricoxib, a selective cox-II-inhibitor (Coxibs), in a prospective randomised double-blind study on bone healing, pain and need for rescue analgesia in patients undergoing elective Hallux Valgus surgery with a standardised surgical technique including an osteotomy of metatarsale I and excision of exostosis.
Study population 100 American Society of Anesthesiology (ASA) physiological status1-2 patients scheduled for elective hallux valgus (HV) surgery
The patients are going to be randomised into 2 groups, 50 patients in each;
First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t. oxycodone 10 mg
Primary study variables:
Secondary study variables are;
Adverse Effects
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Pain |
Drug: etoricoxib Drug: tramadol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | The Effect of Anti-inflammatory Analgesics on Bone Repair, Pain and Gastro-intestinal Side Effects After Hallux Valgus Surgery; a Prospective Randomised Double-blind Placebo Controlled Study. |
| Enrollment: | 100 |
| Study Start Date: | October 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Active study drug: Etoricoxib 90 mg once daily |
Drug: etoricoxib
90 mg once daily
Other Name: Arcoxia
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|
Active Comparator: 2
Tramadol 100 mg slow release twice daily
|
Drug: tramadol
100 mg twice daily
Other Name: Tiparol
|
See brief summary
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Jan Jakobsson, Foot & Ancle Surgical Center |
| ClinicalTrials.gov Identifier: | NCT00733421 History of Changes |
| Other Study ID Numbers: | 2008HV001, EudraCT number 2008-000791-24 |
| Study First Received: | August 12, 2008 |
| Results First Received: | December 7, 2009 |
| Last Updated: | January 15, 2010 |
| Health Authority: | Sweden: Medical Products Agency |
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Day surgery Hallux Valgus Pain Analgesics |
|
Hallux Valgus Pain, Postoperative Foot Deformities Musculoskeletal Diseases Postoperative Complications Pathologic Processes Pain Signs and Symptoms Analgesics Tramadol Etoricoxib Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Antirheumatic Agents Narcotics Central Nervous System Depressants Analgesics, Opioid Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |