Celecoxib in Postoperative Analgesia for Radius Fracture Surgery

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05288374
Study type	Interventional
Source	Charles University, Czech Republic
Contact
Status	Completed
Phase	Phase 4
Start date	February 10, 2022
Completion date	December 31, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05480111` - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy	Phase 4
Completed	`NCT06129305` - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed	`NCT04401826` - Micro-surgical Treatment of Gummy Smile	N/A
Recruiting	`NCT04020133` - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.	N/A
Completed	`NCT03023462` - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair	N/A
Completed	`NCT03546738` - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery	N/A
Completed	`NCT03652103` - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy	Phase 4
Terminated	`NCT03261193` - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain	Phase 3
Withdrawn	`NCT03528343` - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy	Phase 1/Phase 2
Completed	`NCT02525133` - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty	Phase 3
Completed	`NCT03244540` - Regional Analgesia After Cesarean Section	Phase 4
Enrolling by invitation	`NCT05316168` - Post Operative Pain Management for ACL Reconstruction	Phase 3
Recruiting	`NCT04130464` - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management	Phase 4
Enrolling by invitation	`NCT04574791` - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty	N/A
Completed	`NCT04526236` - Influence of Aging on Perioperative Methadone Dosing	Phase 4
Completed	`NCT04073069` - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults	Phase 4
Recruiting	`NCT05351229` - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery	Phase 4
Enrolling by invitation	`NCT05543109` - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block	N/A
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Completed	`NCT04919317` - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.