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Enrolling by invitation NCT04575688

Periarticular Injection Versus Popliteal Block

Phase IV Interventional Foot Surgery Ankle Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exparel, Bupivicaine.
Who it may be relevant to
Registry conditions: Foot Surgery, Ankle Surgery. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Drug Exparel
    Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.
  • Drug Bupivicaine
    Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.

Primary outcome measures

  • Visual Analog Score [Time frame: Postoperative hour 3]
  • Evidence of motor block [Time frame: Postoperative hour 3]
  • Visual Analog Score [Time frame: Postoperative hour 6]
  • Visual Analog Score [Time frame: Postoperative hour 12]
  • Visual Analog Score [Time frame: Postoperative hour 24]
  • Visual Analog Score [Time frame: Postoperative hour 36]
  • Visual Analog Score [Time frame: Postoperative hour 48]
  • Visual Analog Score [Time frame: Postoperative hour 72]
  • Visual Analog Score [Time frame: Postoperative week 2]
  • Visual Analog Score [Time frame: Postoperative week 4-6]
Secondary outcome measures (12)
  • Document pain medication prescribed immediately after surgery [Time frame: Immediately after surgery]
  • Satisfaction with pain control: survey question [Time frame: Postoperative week 2]
  • Neuralgia symptoms: survey question [Time frame: Postoperative week two]
  • Pill count [Time frame: Postoperative week 2]
  • Document pain medication prescribed at postoperative week 2 [Time frame: Postoperative week 2]
  • Satisfaction with pain control: survey question [Time frame: Postoperative week 6]
  • Neuralgia symptoms: survey question [Time frame: Postoperative week 6]
  • Pill count [Time frame: Postoperative week 6]
  • Document pain medication prescribed at postoperative week 6 [Time frame: Postoperative week 6]
  • Satisfaction with pain control: survey question [Time frame: Postoperative week 12]
  • Neuralgia symptoms: survey question [Time frame: Postoperative week 12]
  • Pill count [Time frame: Postoperative week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • A — Germantown

Identifiers

NCT: NCT04575688 · 19-06453-FB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗