Clinical Trial: Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Exparel Pericapsular Injection: A Prospective Evaluation of Postoperative Pain in Bunion Surgery, First Metatarsophalangeal Joint Fusion, and Cheilectomy

Brief Summary: Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).

Detailed Summary: The investigators propose a prospective, randomized, single-blinded study of patients who are electing to undergo an outpatient first metatarsophalangeal (MTP) joint procedure (bunionectomy, 1st MTP fusion, or cheilectomy). As a standard, patients undergoing these procedures are given regional anesthesia (adductor canal block plus popliteal block). Patients are then given prescriptions for oral opioids to manage post-operative pain. The purpose of this study is to determine whether a single intrapopliteal administration of Exparel, in conjunction with the standard of care regional block, improves pain relief and therefore decreases use of post-operative opioids.
Sponsor: OhioHealth

Current Primary Outcome:

  • Opioid Use as Measured by Questionnaire [ Time Frame: Daily through the third day (72 hours) post-surgery ]
    Compare time to first opioid use over 72 hours between groups
  • Total Opioid Use as Measured by Questionnaire [ Time Frame: Daily through the third day (72 hours) post-surgery ]
    Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.


Original Primary Outcome: Opioid Use as Measured by Questionnaire [ Time Frame: 72 Hours ]

Compare time to first opioid use and total opioid use (reported as total morphine equivalents) over 72 hours between groups


Current Secondary Outcome: Pain Relief Measured by Defense and Veterans Pain Scale [ Time Frame: Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery) ]

Evaluate patient-reported pain scores (scale of 0 (no pain) - 10 (worst pain)) at 0, 6, 12, 24, 36, 48, 60, and 72 hours following surgery


Original Secondary Outcome: Pain Relief Measured by Defense and Veterans Pain Scale [ Time Frame: 72 Hours ]

Evaluate patient-reported pain scores (scale of 1-10) at 0, 6, 12, 24, 36, 48, 60, and 72 hours following surgery


Information By: OhioHealth

Dates:
Date Received: July 2, 2015
Date Started: July 2015
Date Completion:
Last Updated: April 14, 2017
Last Verified: July 2016