Celecoxib in Postoperative Analgesia for Radius Fracture Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Celecoxib 100 mg; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jiří Málek, MD; Phone Number: +420737673267; Email: malekj@fnkv.cz
• Study Contact Backup: Name: Alice Kurzova, MD; Phone Number: +420604933660; Email: aliku@seznam.cz

Study Locations

• Czechia
  • Praha, Czechia, 100 00
    • Faculty Hospital Kralovske Vinohrady
  • Praha 3, Czechia, 13000
    • Jiří Málek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Celecoxib; 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; 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 Comparator: Placebo; 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; Administering placebo regularly every 12 hours for 3 days starting at 6 in the morning on the day of surgery; Other Names: Placebo pill

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Faculty Hospital Kralovske Vinohrady
• Investigators: Principal Investigator: Jiří Málek, MD, 3rd Medical Faculty of Charles University and Faculty Hospital Kralovske Vinohrady

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Celecoxib; Distal radius fracture; Postoperative pain; Osteosynthesis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Pain, Postoperative; Radius Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: Celecoxib in radius fracture

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No