Pain Control Methods for Ankle Surgery
(PvP Trial)

Recruiting in Palo Alto (17 mi)

Overseen byGarnett A Murphy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Campbell Clinic

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Garnett A Murphy, MD

Principal Investigator

Campbell Clinic

Eligibility Criteria

This trial is for adults aged 18-80 who need foot or ankle surgery and can follow the study plan, including all visits. They must be healthy enough for surgery (ASA I-III), speak English, and have their operation at Campbell Surgery Center. People with diabetes must have an Hbg A1C of 7 mg/dl or less. Those with chronic pain conditions, peripheral neuropathy, long-term narcotic use, or allergies to certain anesthetics cannot join.

Inclusion Criteria

My surgery is scheduled at Campbell Surgery Center in Germantown, TN.

I have had surgery to correct bone structure in my ankle or to repair a broken ankle.

ASA I-III with medical clearances as needed

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Exclusion Criteria

You have been taking strong painkillers for a long time before the surgery.

I have been diagnosed with chronic pain syndrome.

Hbg A1C is > 7 mg/dl in diabetic patients only

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Treatment Details

Interventions

Bupivicaine (Local Anesthetic)
Exparel (Local Anesthetic)

Trial OverviewThe study compares two pain control methods after foot or ankle bone surgery: a periarticular injection using Exparel versus a popliteal block with Bupivicaine. The goal is to see which one is more effective and safer for managing post-surgery pain.

Participant Groups

2Treatment groups

Active Control

Group I: Periarticular InjectionActive Control1 Intervention

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.

Group II: Popliteal BlockActive Control1 Intervention

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.