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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative week 6

Awards & highlights

PvP Trial 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.Check my eligibility

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.See study design

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.

PvP Trial 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.

PvP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evidence of motor block

Visual Analog Score

Secondary outcome measures

Document pain medication prescribed at postoperative week 12

Pharmaceutical Preparations

Document pain medication prescribed at postoperative week 6

+4 more

PvP 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Campbell ClinicLead Sponsor

10 Previous Clinical Trials

1,722 Total Patients Enrolled

Garnett A Murphy, MDPrincipal InvestigatorCampbell Clinic

Media Library

Periarticular Injection Clinical Trial Eligibility Overview. Trial Name: NCT04575688 — Phase 4

Foot Surgery Research Study Groups: Periarticular Injection, Popliteal Block

Foot Surgery Clinical Trial 2023: Periarticular Injection Highlights & Side Effects. Trial Name: NCT04575688 — Phase 4

Periarticular Injection 2023 Treatment Timeline for Medical Study. Trial Name: NCT04575688 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current amount of participants in this trial?

"At present, this research protocol is not enrolling any new participants. The initial posting was on July 13th 2021 with the most recent update occurring in October 14 2022. If you are searching for alternative studies, there are presently 4 clinical trials recruiting patients suffering from foot pain and 109 medical investigations currently admitting individuals requiring Periarticular Injections."

Answered by AI

Is recruitment still happening for this clinical trial?

"Based on the data available on clinicaltrials.gov, this trial is not presently seeking participants as it was last updated in October of 2022. Nevertheless, 113 other studies are actively admitting applicants at this juncture."

Answered by AI

Has Periarticular Injection received clearance from the FDA?

"With Phase 4 trials affirming Periarticular Injection's efficacy, our team at Power has rated its safety as a 3 on a scale from 1 to 3."

Answered by AI

What maladies tend to be treated using Periarticular Injection?

"Permphigus is usually managed with the use of Periarticular Injection. This method can also be employed to mitigate acute nonspecific tenosynovitis, general anesthesia and lupus erythematosus cell symptoms."

Answered by AI

Who has been deemed most suitable for inclusion in this experiment?

"Eligibility criteria for the trial require prospective participants to have a certain medical condition and be between 18-80 years of age. There is space for roughly one hundred individuals in this investigation."

Answered by AI

Is the age restriction on this trial inclusive to minors?

"According to the eligibility parameters, all prospective participants ought to be aged 18 or above and 80 or below."

Answered by AI

Can you provide an overview of the prior research done on Periarticular Injection?

"As of now, 109 medical trials are researching Periarticular Injection with 18 entering Phase 3. Of these studies, Philadelphia Pennsylvania is hosting several; however, there are 144 clinical sites involved in total."

Answered by AI

Could you please elucidate the primary aims of this research project?

"The primary endpoint of this 12 week trial is to analyse the degree of motor block. The secondary outcomes involve patient reported satisfaction with their pain management on a seven-point likert scale, whether they experience neuralgia symptoms, and what kind of postoperative medication was prescribed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Periarticular Injection Versus Popliteal Block

2021. "Periarticular Injection Versus Popliteal Block". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04575688.

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