The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery

Study Overview
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Brief Summary
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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; etoricoxib 90 mg once daily x 5 tramadol 100 mg twice daily x 5 First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t. oxycodone 10 mg Primary study variables: X-ray evaluation (computer tomography (CT)-investigation) of bone healing assessed a CT-scan modelling of the osteotomy at twelve weeks after surgery Number of patients requiring rescue medication Patient assessment using brief pain inventory 24 hours and 2 weeks after surgery Secondary study variables are; Visual Analogue Scale (VAS) grading Day 1-7 Compliance to base medication Need for rescue analgesia Day 1-7 Adverse Effects Experience of any emetic symptoms Experience of any gastrointestinal symptoms Satisfaction with pain medication Day 20 Wound dressing Day 20 Clinical evaluation 17 weeks, final assessment

Detailed Description
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See brief summary

Official Title
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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.

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: etoricoxib
* Drug: tramadol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health ASA 1-2 patients 18-65 years of age Exclusion Criteria: ASA/NSAID allergy Renal disease Lithium therapy Complicated cardiovascular disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Experimental: 1<br>Active study drug: Etoricoxib 90 mg once daily | Drug: etoricoxib<br>* 90 mg once daily<br>* Other names: Arcoxia;|
| Active Comparator: 2<br>Tramadol 100 mg slow release twice daily | Drug: tramadol<br>* 100 mg twice daily<br>* Other names: Tiparol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Requiring Rescue Medication | Number of patients requiring any further pain medication | 7 day study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain | VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70 | The first 7 days after surgery, during study pain medication | 
| Compliance to Base Medication | Number of patients that did not discontinue study medication before day 7 | 7-day study period, during study medication | 
| Gastro-intestinal Symptoms | Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire | during the 7- day pain medication period | 
| Dizziness/Sleepiness | Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire | During the 7-day pain medication period | 
| Wound Healing | healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad | 16 week follow-up | 
| Satisfaction With Pain Medication | satisfied or unsatisfied with study medication, assessed by patient in questionnaire | during the first 20 days after surgery, 1st outpatient clinic visit | 
| Patient Assessed Overall Satisfaction With Surgery/Outcome | overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire. | 16 weeks | 
| Patient Assessed Quality of Life | Quality of Life evaluated by grading on a Visual Analogue Scale in the written questionnaireisual analogue scale grading 0-100; 0 death and 100 perfect quality of life | At 16-week post surgery follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Day surgery, Hallux Valgus, Pain, Analgesics