Celecoxib in Postoperative Analgesia for Radius Fracture Surgery

Study Overview
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Brief Summary
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Patients scheduled for elective osteosynthesis of the distal radius will be randomized to receive celecoxib 100 mg orally (PO) at 6 in the morning before surgery and every 12 hours for 2 days thereafter, or a placebo pill in the same regimen. After surgery under general anaesthesia, they will receive paracetamol 1 g intravenously (IV) every 6 hours and if pain intensity is greater than 4 on a numeric rating scale (NRS) of 0-10, piritramid 15 mg intramuscularly (IM) will be administered. Pain intensity, piritramid consumption and side effects of treatment will be recorded in a questionnaire for 2 days.

Detailed Description
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A prospective single-blinded randomized study will be performed in patients of the Orthopaedic Clinic of the 3rd Medical Faculty of Charles University (3LF UK) and the Faculty Hospital Kralovske Vinohrady (FHKV) scheduled for elective osteosynthesis of the distal radius. The expected number of participants is 25 in each arm of the study. They will be randomized by envelope method into an non-steroidal analgesic (NSA) group, which will receive celecoxib at 6 in the morning before surgery, and a C group, which will receive a placebo pill prepared by the hospital pharmacy. General anesthesia will be performed in both groups in the standard way using propofol, sufentanil and sevoflurane 1 minimal alveolar concentration (MAC) with air and oxygen at 40% concentration. At the end of surgery, each patient will be given paracetamol 1 g intravenously (IV) and ondansetron 4 mg IV. Pain intensity after surgery will be measured on a numerical rating scale (NRS) 0-10. For postoperative analgesia, both groups will receive paracetamol 1 g IV. every 6 hours, and for NRS>4 pain intensity, piritramid 15 mg intramuscularly (IM). The NSA group will receive celecoxib 100 mg orally (PO) at 6 in the morning and 6 in the afternoon, and group C will receive placebo at the same interval. Parameters to be monitored will be postoperative pain intensity for the primary objective, and opioid piritramid consumption and side effects of the treatment for the secondary objectives. NRS, number of doses of piritramid and side effects will be recorded in a coded questionnaire.

Official Title
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Celecoxib for Treatment of Postoperative Pain After Osteosynthesis of Distal Radius Fracture

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Celecoxib 100 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for osteosynthesis of distal radius fracture Exclusion Criteria: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Patients who have demonstrated allergic-type reactions to sulfonamides. Inability to understand the questionnaire

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
Interventional Model Description: Celecoxib 100 mg orally on the day of surgery at 6 in the morning and will be continued regularly at 6 in the morning and 6 in the afternoon for 3 days.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br>Celecoxib 100 mg orally will be administered in the day of surgery at 6 in the morning and will be continued regularly at 6 in the morning and 6 in the afternoon for 3 days. | Drug: Celecoxib 100 mg<br>* Administering Celecoxib 100 mg (Celebrex) regularly every 12 hours for 3 days starting at 6 in the morning on the day of surgery<br>* Other names: Celebrex 100 mg;|
| Placebo Comparator: Placebo<br>A placebo pill provided by a hospital pharmacy will be administered in the day of surgery at 6 in the morning and 6 in the afternoon for 3 days. | Drug: Placebo<br>* Administering placebo regularly every 12 hours for 3 days starting at 6 in the morning on the day of surgery<br>* Other names: Placebo pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain intensity | Intensity of pain measured by numeric rating scale (NRS) 0-10 | up to 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of piritramid injection | Piritramid 15 mg intramuscularly will be administered if numeric rating scale (NRS 0-10) of pain is NRS>4 | 3 days | 
| Side effects of treatment | Incidence of stomach pain, heartburn, gas, diarrhea, constipation, nausea, vomiting, dizziness, others | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Distal radius fracture, Osteosynthesis, Celecoxib