Periarticular Injection Versus Popliteal Block (PvP)

Campbell Clinic

Status and phase: Invitation-only; Phase 4

Conditions: Foot Surgery; Ankle Surgery

Treatments: Drug: Exparel; Drug: Bupivicaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04575688

19-06453-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Periarticular Injection

Active Comparator group

Description:

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.

Treatment:

Drug: Exparel

Popliteal Block

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivicaine