Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

OhioHealth2 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Bunion Hallux Rigidus

Interventions

0.5% ropivacaineDRUG

Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine

ExparelDRUG

106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 * Undergoing distal or midshaft osteotomy for bunion correction, 1st MTP Fusion, or cheilectomy Exclusion Criteria: * Age less than 18 * Unable to read/write English * Dementia, history of dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting * Weight \<70 kg * Allergy to local anesthetics * History of long-acting opioid use or opioid tolerance (any patient receiving at least 30 mg of oxycodone or equivalent per day (e.g., 6 tabs of Percocet 5/325 mg) regularly for approximately 7 days or more OR who require increased analgesic doses for a period long enough to develop tolerance to the effects of the opioid including analgesia and sedation) * Any history of opioid misuse, illicit or prescription * Prior MTP joint correction on the surgical limb * Midfoot and hindfoot procedures performed concurrently, on the same day * Pregnant or breastfeeding

Locations (2)

Grant Medical Center

Columbus, Ohio, United States

Orthopedic Foot and Ankle Center

Westerville, Ohio, United States

Outcomes

Primary Outcomes

Opioid Use as Measured by Questionnaire

Compare time to first opioid use over 72 hours between groups

Time frame: Daily through the third day (72 hours) post-surgery

Total Opioid Use as Measured by Questionnaire

Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.

Time frame: Daily through the third day (72 hours) post-surgery

Secondary Outcomes

Pain Relief Measured by Defense and Veterans Pain Scale

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

Time frame: Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)

Data from ClinicalTrials.gov

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