Phase III Study Comparing Standard Pain Management With and Without NSAIDs for Tibial Shaft Fractures Evaluating Effects on Bone Healing, Opioid Use, and Pain Control

What this Trial Is About

Researchers are evaluating the use of nonsteroidal anti-inflammatory drugs NSAIDs as part of pain management for patients with tibial shaft fractures treated with intramedullary nails. This Phase III, randomized controlled trial compares standard pain management without NSAIDs to standard pain management plus up to six weeks of NSAIDs. The study aims to determine whether adding NSAIDs affects bone healing, pain control, opioid use, side effects, and functional outcomes over one year. Participants are randomly assigned to one of two groups. The treatment group receives oral ibuprofen 600 mg three times daily for up to six weeks, with additional pain relief as needed but excluding other NSAIDs. The control group receives standard pain management without NSAIDs but may use other analgesics. Physicians may prescribe misoprostol if there are concerns about NSAID use with anticoagulation. Both groups are monitored for up to 12 months after injury. During the study, participants undergo regular assessments to measure the need for additional surgery to promote bone healing, opioid use, side effects, persistent pain, pain interference, physical and psychosocial function, and radiographic evidence of bone union. The trial includes safety monitoring and aims to collect outcomes at one year. Participants are expected to attend follow-up visits at clinical sites for evaluations and data collection throughout the study period.

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial