Clinical trial NCT05288374: Celecoxib in Postoperative Analgesia for Radius Fracture Surgery
Official title: Celecoxib for Treatment of Postoperative Pain After Osteosynthesis of Distal Radius Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Postoperative pain
Distal radius fracture
Osteosynthesis
Celecoxib
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Faculty Hospital Kralovske Vinohrady
First posted: 2022-03-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative pain intensity
timeFrame: up to 2 days
Secondary outcomes:
measure: Number of piritramid injection
timeFrame: 3 days
measure: Side effects of treatment
timeFrame: 3 days
Other outcomes:
Locations:
city: Praha 3
country: Czechia
facility: Jiří Málek
city: Praha
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
Study officials:
affiliation: 3rd Medical Faculty of Charles University and Faculty Hospital Kralovske Vinohrady
name: Jiří Málek, MD
role: PRINCIPAL_INVESTIGATOR
References: