NSAID Use and Healing After Tibia Fractures and Achilles Tendon Ruptures

• Status: Unknown status
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Rationale: The Emergency Department (ED) typically serves as the front line for patients with acute fractures and tendon ruptures. Pain control for these patients is an essential task of the ED physician. With the advent of the opioid epidemic, ED physicians are becoming more inclined to prescribe non-narcotic pain medications such as non-steroidal anti-inflammatory drugs (NSAIDs). Yet, the effects of NSAIDs on musculoskeletal healing are controversial. The few human studies examining the effects of NSAID use on fracture healing have provided conflicting results. Even less is known about the effects of NSAIDs on tendon healing as this information has largely been gleaned from rodent studies with contradictory findings. There has never been a large, prospective, randomized, double-blinded study to determine the effects of NSAIDs on healing after fractures or tendon ruptures. Here, I propose to pilot the first prospective, randomized, double-blinded study examining the effects of NSAID use on healing after tibia fractures and Achilles tendon ruptures.

Aim 1 seeks to determine whether NSAID use is associated with an increased incidence of fracture nonunion and worse functional recovery six months following tibia fractures. I hypothesize that NSAID use after tibia fractures will be associated with an increased incidence of fracture nonunion and worse functional recovery. Aim 2 seeks to determine whether NSAID use is associated with worse functional recovery six months after Achilles tendon ruptures. I hypothesize that NSAID use after Achilles tendon ruptures will be associated with worse functional recovery.

Significance: Emergency Department providers commonly prescribe NSAIDs for pain control following fractures and tendon injuries. However, the implications of this practice on bone and tendon healing are unknown. This proposal will pilot the first prospective, randomized, double-blinded study to determine whether NSAID use affects healing after tibia fractures and Achilles tendon ruptures. Results from this study will impact NSAID prescribing patterns for tibia fractures and Achilles tendon ruptures in the ED, either by demonstrating that they impair recovery and should be avoided, or that they need not be withheld as an effective non-narcotic form of pain control.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion:

• Adult patients (over 18) presenting within 24 hours of a tibia fracture

• Adult patients (over 18) presenting within 24 hours of an Achilles tendon rupture

Exclusions:

Patients will be excluded if they:

• have a contraindication to Ibuprofen or Acetaminophen use

• don't have access to e-mail

• require emergent surgery (such as an open fracture)

• have a diagnosis of osteoporosis

• have already taken one of the study drugs since their injury

• are pregnant (due to their inability to take NSAIDs)

• are < 18 years old (due to differences in bone and tendon healing).