The Effectiveness of Perioperative Parecoxib Intravenous Administration in the Surgical Fixation of Unstable Ankle Fracture: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Trial.
Phase 3
Completed
- Conditions
- The patients with unstable ankle fractures who have surgical indications.AnalgesiaAnkle fracturesparecoxibperioperativerandomised controlled trial
- Registration Number
- TCTR20210416003
- Lead Sponsor
- American Orthopaedic Foot & Ankle Society
- Brief Summary
Perioperative administration of parecoxib could not significantly provide better postoperative pain control and lower amount of opioid requirement than placebo. Single benefit of perioperative use of parecoxib seemed to be shorter length of hospital stay than placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
The patient with unstable ankle fracture who had the indication for open reduction and internal fixation.
Exclusion Criteria
The contraindication of parecoxib use (1 pateint), thrombocytopenia on preoperative blood work (1 patient), head injury with contraindication for spinal anesthesia (1 patient), and acute on chronic fracture (1 patient).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain and related scores, amount of morphine used Time 0 was recorded when the patients were move to the post-anesthesia care unit (PACU) after surgery. The VNRS and VNRP were recorded at 0, 4, 12, 24 and 48 hours after surgery by trained personnel. verbal numerical rating score, verbal numerical rating percentage, patient subjective rating of the medication, amount of intravenous morphine administered, overall adverse effects
- Secondary Outcome Measures
Name Time Method /A N/A N/A