Status:
COMPLETED
Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study
Lead Sponsor:
Prisma Health-Midlands
Conditions:
Bunion of Unspecified Foot
Bunionette of Unspecified Foot
Eligibility:
All Genders
18-99 years
Brief Summary
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 multimo...
Detailed Description
Despite the presence and increased understanding of the opioid crisis in the United States, orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperati...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- \<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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 26 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04771741
Start Date
December 1 2020
End Date
April 26 2023
Last Update
April 27 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Prisma Health Midlands
Columbia, South Carolina, United States, 29203