Clinical trial NCT04771741: Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study
Official title: Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bunion of Unspecified Foot
Bunionette of Unspecified Foot
Hammertoe
Ankle Fractures
Achilles Tendon Surgery
Lead sponsor: Prisma Health-Midlands
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Included in this study will be adult outpatient, elective, primary foot and ankle surgery that is not due to infection performed at Prisma Health Orthopedics.

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 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.

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 postoperative period. In an effort to minimize narcotic analgesia and its potential side effects, opioid-free multimodal pathways have been developed in many orthopaedic sub-specialties with promising results. There have been early studies reporting the results of non-narcotic protocols during the intra-operative period. Likewise, there have been several studies reporting the results of inpatient non-narcotic pain protocols in select foot and ankle surgeries. However, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. Currently, our practice utilizes an opioid-free post-operative pain protocol for patients undergoing elective outpatient foot and ankle surgery. The goal of this study is to evaluate post-operative pain using this opioid-free multimodal pain protocol at days 1,3, and 8 following elective outpatient foot and ankle surgery.

Eligibility criteria: Inclusion Criteria:

* ≥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 Criteria:

* \<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

Primary outcomes:
measure: Patient satisfaction with opioid-free multimodal postoperative protocol.
timeFrame: 2 weeks
measure: Rate of failure of opioid-free multimodal postoperative protocol.
timeFrame: 2 weeks
Secondary outcomes:
measure: Post-operative Pain: Day 1
timeFrame: 1 day
measure: Post-operative Pain: Day 3
timeFrame: 3 days
measure: Post-operative Pain: Day 8
timeFrame: 8 days
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Prisma Health Midlands
state: South Carolina
Study officials:
affiliation: Prisma Health-Midlands
name: J. Benjamin Jackson, MD, MBA
role: PRINCIPAL_INVESTIGATOR
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