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Completed

NCT Number: NCT05288374

Celecoxib in Postoperative Analgesia for Radius Fracture Surgery

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.

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Key information

Conditions

Pain, Postoperative Arm Injuries Fractures, Bone Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty Hospital Kralovske Vinohrady, Prague, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib 100 mg

Drug

Administering Celecoxib 100 mg (Celebrex) regularly every 12 hours for 3 days starting at 6 in the morning on the day of surgery

Other names: Celebrex 100 mg

Placebo

Drug

Administering placebo regularly every 12 hours for 3 days starting at 6 in the morning on the day of surgery

Other names: Placebo pill

Primary outcomes

  1. Postoperative pain intensity

    Time frame: up to 2 days

    Intensity of pain measured by numeric rating scale (NRS) 0-10

Secondary outcomes

  1. Number of piritramid injection

    Time frame: 3 days

    Piritramid 15 mg intramuscularly will be administered if numeric rating scale (NRS 0-10) of pain is NRS>4

  2. Side effects of treatment

    Time frame: 3 days

    Incidence of stomach pain, heartburn, gas, diarrhea, constipation, nausea, vomiting, dizziness, others

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Faculty Hospital Kralovske Vinohrady

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2022
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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