A Randomized Controlled Trial Comparing a Periarticular Injection to a Popliteal Block for Pain Control in Ankle/Hindfoot Osteotomy or Fusion and Ankle Fractures
Overview
- Phase
- Phase 4
- Intervention
- Bupivicaine
- Conditions
- Foot Surgery
- Sponsor
- Campbell Clinic
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Visual Analog Score
- Status
- Enrolling by Invitation
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
This is a prospective, randomized, controlled research study of two perioperative standards of care for managing post operative pain. The first standard of care procedure is the periarticular injection; the second is the popiteal block.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Popliteal Block
Subjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a popliteal block by the anesthesiologist using 30 milliliters of bupivicaine 0.5 percent in the pre-operative area, prior to surgery, using an ultrasound machine for guidance.
Intervention: Bupivicaine
Periarticular Injection
Subjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a periarticular injection by the surgeon using 10 milliliters of Exparel mixed with 10 milliliters of bupivicaine 0.5 percent at the end of the procedure.
Intervention: Exparel
Outcomes
Primary Outcomes
Visual Analog Score
Time Frame: Postoperative week 12
Patient reported pain score from zero to ten where zero is no pain and ten is the most pain
Evidence of motor block
Time Frame: Postoperative hour 3
Patient reported yes/no answer to survey question: "Are you able to wiggle your toes?"
Secondary Outcomes
- Document pain medication prescribed immediately after surgery(Immediately after surgery)
- Neuralgia symptoms: survey question(Postoperative week 12)
- Pill count(Postoperative week 12)
- Document pain medication prescribed at postoperative week 2(Postoperative week 2)
- Document pain medication prescribed at postoperative week 6(Postoperative week 6)
- Satisfaction with pain control: survey question(Postoperative week 12)
- Document pain medication prescribed at postoperative week 12(Postoperative week 12)