Periarticular Injection Versus Popliteal Block

NCT04575688 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 19-06453-FB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Foot Surgery; Ankle Surgery

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (13)

• Document pain medication prescribed immediately after surgery

  Immediately after surgery

• Satisfaction with pain control: survey question

  Postoperative week 2

• Neuralgia symptoms: survey question

  Postoperative week two

• Pill count

  Postoperative week 2

• Document pain medication prescribed at postoperative week 2

  Postoperative week 2

Study Arms (2)

Periarticular Injection

ACTIVE COMPARATOR

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

Popliteal Block

ACTIVE COMPARATOR

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

Interventions

Exparel DRUG

Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.

Also known as: Periarticular Injection

Periarticular Injection

Bupivicaine DRUG

Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.

Also known as: Peripheral Nerve Injection

Popliteal Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ankle or hindfoot osteotomy or ankle fracture repair
• Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campbell Clinic: lead

Study Sites (1)

A

Germantown, Tennessee, 38138, United States

Location

Study Officials

• Garnett A Murphy, MD

  Campbell Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 5, 2020
• Study Start: July 13, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)