Periarticular Injection Versus Popliteal Block

Part of paid clinical trials in Germantown, Tennessee.

Sponsor
Campbell Clinic
Study ID
NCT04575688
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Ankle Surgery
  • Foot Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jul 13, 2021
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Visual Analog Score [ Time Frame: Postoperative hour 3 ]

Locations (1)

FacilityCityStateZIPSite coordinators
AGermantownTennessee38138-

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