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Periarticular Injection Versus Popliteal Block

NCT ID: NCT04575688

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Foot Surgery Ankle Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Exparel

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Bupivicaine

Intervention Type DRUG

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

Interventions

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Exparel

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

Intervention Type DRUG

Bupivicaine

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

Intervention Type DRUG

Other Intervention Names

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Periarticular Injection Peripheral Nerve Injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campbell Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Garnett A Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Campbell Clinic

Locations

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A

Germantown, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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19-06453-FB

Identifier Type: -

Identifier Source: org_study_id