Celecoxib in Postoperative Analgesia for Radius Fracture Surgery

NCT05288374 | Completed Phase 4

• 1 other identifier: Celecoxib in radius fracture
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain, Postoperative

Keywords

Postoperative pain; Distal radius fracture; Osteosynthesis; Celecoxib

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

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

  up to 2 days

Secondary Outcomes (2)

• Number of piritramid injection

  3 days

• Side effects of treatment

  3 days

Study Arms (2)

Celecoxib

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Celebrex 100 mg

Celecoxib

Placebo DRUG

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

Also known as: Placebo pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for osteosynthesis of distal radius fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Faculty Hospital Kralovske Vinohrady: collaborator

Study Sites (2)

Faculty Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

Location

Jiří Málek

Prague, 13000, Czechia

Location

MeSH Terms

Conditions

Pain, Postoperative; Wrist Fractures

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jiří Málek, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo pill provided by a hospital pharmacy will be administered 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Jiri Malek, MD, Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 21, 2022
• Study Start: February 10, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CZ (2)