A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery

NANot yet recruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

July 1, 2026

Study Completion Date

July 1, 2026

Conditions
Ankle (Ligaments); Instability (Old Injury)Ankle SprainTalus Osteochondral DefectOpioid AnalgesiaNon-Opioid Pain Management
Interventions
DRUG

Opioid Analgesic Regimen

Participants will take 5 mg/325 mg of oxycodone - acetaminophen every 6 hours as needed for pain, with a maximum of 4 doses per day. Rescue analgesia protocol: a limited rescue prescription of oxycodone/acetaminophen (containing 5 mg oxycodone), to be taken every 2 hours as needed, with no more than 10 tablets per day, and only if adequate pain relief is not achieved (defined as NRS score ≥ 4).

DRUG

Non-opioid analgesic regimen

Immediately after surgery, patients will receive oral acetaminophen 500 mg plus celecoxib 400 mg. Thereafter, celecoxib 200 mg BID and acetaminophen 500 mg Q6H will be administered. Rescue analgesia protocol: a limited rescue prescription of oxycodone/acetaminophen (containing 5 mg oxycodone), to be taken every 2 hours as needed, with no more than 10 tablets per day, and only if adequate pain relief is not achieved (defined as NRS score ≥ 4).

Trial Locations (1)

310000

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

NCT07154433 - A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery | Biotech Hunter | Biotech Hunter