Celecoxib in Postoperative Analgesia for Radius Fracture Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05288374
• Other study ID #: Celecoxib in radius fracture
• Status: Completed
• Phase: Phase 4
• Start date: February 10, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Radius Fractures

Intervention

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

Locations

Country	Name	City	State
Czechia	Faculty Hospital Kralovske Vinohrady	Praha
Czechia	Jirí Málek	Praha 3

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain intensity	Intensity of pain measured by numeric rating scale (NRS) 0-10	up to 2 days
Secondary	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
Secondary	Side effects of treatment	Incidence of stomach pain, heartburn, gas, diarrhea, constipation, nausea, vomiting, dizziness, others	3 days