Celecoxib in Postoperative Analgesia for Radius Fracture Surgery

NCT ID: NCT05288374

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2023-12-31

Brief 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.

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Celecoxib 100 mg

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Celebrex 100 mg; Placebo pill

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role: collaborator

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Jiri Malek

Assoc. Prof. Jiri Malek, MD, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiří Málek, MD

Role: PRINCIPAL_INVESTIGATOR

3rd Medical Faculty of Charles University and Faculty Hospital Kralovske Vinohrady

Locations

Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

Jiří Málek

Prague, , Czechia

Countries

Czechia

Other Identifiers

Celecoxib in radius fracture

Identifier Type: -

Identifier Source: org_study_id