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Pain Control Methods for Ankle Surgery (PvP Trial)

Phase 4

Waitlist Available

Led By Garnett A Murphy, MD

Research Sponsored by Campbell Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138)

Ankle or hindfoot osteotomy or ankle fracture repair

Must not have

Diagnosed with chronic pain syndrome

Diagnosed with peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative week 6

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will study two common procedures for controlling pain after ankle surgery.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects from Exparel and Bupivicaine include reactions at the injection site like swelling or itching, nerve damage symptoms such as numbness or weakness, nausea, headaches, fever, backache; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with chronic pain syndrome.

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I have been diagnosed with peripheral neuropathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evidence of motor block

Visual Analog Score

Secondary study objectives

Document pain medication prescribed at postoperative week 12

Pharmaceutical Preparations

Document pain medication prescribed at postoperative week 6

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met