Periarticular Injection Versus Popliteal Block (PvP)

A Randomized Controlled Trial Comparing a Periarticular Injection to a Popliteal Block for Pain Control in Ankle/Hindfoot Osteotomy or Fusion and Ankle Fractures

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Foot Surgery; Ankle Surgery
• Intervention / Treatment: Drug: Exparel; Drug: Bupivicaine

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • A

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Exparel; Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.; Other Names: Periarticular Injection
Active Comparator: 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.	Drug: Bupivicaine; Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.; Other Names: Peripheral Nerve Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 3
Evidence of motor block	Patient reported yes/no answer to survey question: "Are you able to wiggle your toes?"	Postoperative hour 3
Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 6
Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 12
Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 24
Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 36
Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 48
Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 72
Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative week 2
Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative week 4-6
Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Document pain medication prescribed immediately after surgery	Pain medication prescribed immediately after the surgery will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed immediately after surgery, to include opiate name, dose, and number of pills prescribed.	Immediately after surgery
Satisfaction with pain control: survey question	Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.	Postoperative week 2
Neuralgia symptoms: survey question	Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia.	Postoperative week two
Pill count	Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."	Postoperative week 2
Document pain medication prescribed at postoperative week 2	Pain medication prescribed at postoperative week 2 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 2, to include opiate name, dose, and number of pills prescribed.	Postoperative week 2
Satisfaction with pain control: survey question	Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.	Postoperative week 6
Neuralgia symptoms: survey question	Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia.	Postoperative week 6
Pill count	Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."	Postoperative week 6
Document pain medication prescribed at postoperative week 6	Pain medication prescribed at postoperative week 6 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 6, to include opiate name, dose, and number of pills prescribed.	Postoperative week 6
Satisfaction with pain control: survey question	Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.	Postoperative week 12
Neuralgia symptoms: survey question	Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia.	Postoperative week 12
Pill count	Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."	Postoperative week 12
Document pain medication prescribed at postoperative week 12	Pain medication prescribed at postoperative week 12 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 12, to include opiate name, dose, and number of pills prescribed.	Postoperative week 12

Collaborators and Investigators

• Sponsor: Campbell Clinic
• Investigators: Principal Investigator: Garnett A Murphy, MD, Campbell Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimated): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: 19-06453-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes