What this study is
This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.
What's being tested
- Exparel
Intervention · DRUG
Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.
- Bupivicaine
Intervention · DRUG
Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.
Study details
- Official title
- A Randomized Controlled Trial Comparing a Periarticular Injection to a Popliteal Block for Pain Control in Ankle/Hindfoot Osteotomy or Fusion and Ankle Fractures
- Sponsor
- Campbell Clinic
- Conditions
- Foot Surgery · Ankle Surgery
- Enrolling
- 100 people
- Starts
- 2021-07-13
- Est. completion
- 2027-02-28
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Ankle or hindfoot osteotomy or ankle fracture repair
- Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138)
- 18-80 years of age
- ASA I-III with medical clearances as needed
- Fluent ub verbal and written English
- Willing and able to comply with study instruction and commit to all follow-up visits for theduration of the study
- Willing and able to provide written consent
You can't join if
- Diagnosed with chronic pain syndrome
- History of allergic reactions to lidocaine, marcaine, Experal, bupivicaine, or other injectable anesthetic agents
- Injury associated with workers' compensation
- Surgery to be performed at a hospital
- Diagnosed with peripheral neuropathy
- Hbg A1C is > 7 mg/dl in diabetic patients only
- Long term (chronic) preoperative narcotic usage
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openA
Germantown, Tennessee, United States
Study team
Sponsor
Campbell Clinic
Study ID 19-06453-FB
Principal investigator
Garnett A Murphy, MD
Campbell Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.