Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study
Completed
Conditions studied: Bunion of Unspecified Foot, Bunionette of Unspecified Foot, Hammertoe, Ankle Fractures, Achilles Tendon Surgery
In brief
Orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period, despite the ongoing opioid crisis in the United States. While opioid-free multimodal pathways have shown promising results, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. This study aims to evaluate post-operative pain following the use of an opioid-free pain treatment plan for patients undergoing foot and ankle surgeries.
Key facts
- Study ID
- NCT04771741
- Run by
- Prisma Health-Midlands
- People needed
- 72
- Starts
- 2020-12-01
- Expected to finish
- 2023-04-26
- Last updated by the study team
- 2023-04-27
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥18 years of age
- Outpatient, elective, primary foot and ankle surgery not due to infection including:
- Bunion or bunionette surgery, hammertoe surgery, ankle fracture, Achilles tendon surgery (primary mid-substance repair, Haglund's deformity correction with debridement), ankle arthroscopy
You may not qualify if…
- <18 years of age
- Undergoing revision surgery
- Allergic to more than 1 medication listed in protocol
- Creatinine clearance >1.5
- Known end-stage renal, stage 2 or higher
- History of GI bleed, ulcer, NSAID-induced gastritis, and/or gastric bypass
- History of active liver disease or Child-Pugh Class 2 liver failure or above
- History of pain syndromes including: fibromyalgia, complex regional pain syndrome/reflex sympathetic dystrophy, hyperalgesia
- Inability to undergo regional anesthesia due to inability to obtain nerve block, prior nerve damage or anatomy, or anesthesiologic best judgement
- Currently pregnant
Where it is running
- Prisma Health Midlands — Columbia, South Carolina, United States
Full record on ClinicalTrials.gov
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