Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

Study Overview
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Brief Summary
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To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Assessment Of The Analgesic Efficacy Of The Dosing Regimen Of Valdecoxib Compared To Placebo Patients In Pain Following Bunionectomy

Conditions
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Pain, Post-surgical

Intervention / Treatment
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* Drug: valdecoxib
* Drug: valdecoxib/placebo
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) requiring open manipulation of bone with periosteal elevation under regional anesthesia (Mayo block) Patients had a Baseline pain intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS Exclusion Criteria: Patients who were scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone Patients treated with patient controlled analgesia (PCA) subsequent to the end of anesthesia Patients treated with long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space Patients expected to require analgesics or other agents other than study medication during the 8 hours preceding administration of study medication through the end of the treatment period, that could confound assessment of the analgesic response, specifically excluded were tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, cyclooxygenase-2 inhibitors, nonsteroidal antiinflammatory drugs, and corticosteroids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: valdecoxib<br>* valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose<br>|
| Active Comparator: Arm 2<br> | Drug: valdecoxib/placebo<br>* valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose<br>|
| Placebo Comparator: Arm 3<br> | Drug: placebo<br>* placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24) |  | Day 1 | 
| Total Pain Relief through 24 hours (TOTPAR 24) |  | Day 1 | 
| Patient's Global Evaluation of Study Medication |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time between doses of study medication |  | Day 1 | 
| Time-specific Pain Intensity Difference (PID) (categorical) |  | 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours | 
| time-specific pain relief |  | 2, 4, 6, 8, 10, 12, 16, and 24 hours | 
| time-specific PID (VAS) |  | 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours | 
| Summed Pain Intensity (SPID)24 (VAS) |  | 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours | 
| time to rescue medication |  | 2, 4, 6, 8, 10, 12, 16, and 24 hours | 
| percent of patients who took rescue medication |  | Day 1 | 
| Patient's Satisfaction Questionnaire |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hallux valgus