Clinical trial NCT02499575: Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures
Official title: Exparel Pericapsular Injection: A Prospective Evaluation of Postoperative Pain in Bunion Surgery, First Metatarsophalangeal Joint Fusion, and Cheilectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bunion
Hallux Rigidus
Keywords: Exparel
bupivacaine
Hallux valgus deformity
bunionectomy
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid Use as Measured by Questionnaire
timeFrame: Daily through the third day (72 hours) post-surgery
measure: Total Opioid Use as Measured by Questionnaire
timeFrame: Daily through the third day (72 hours) post-surgery
Secondary outcomes:
measure: Pain Relief Measured by Defense and Veterans Pain Scale
timeFrame: Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Westerville
country: United States
facility: Orthopedic Foot and Ankle Center
state: Ohio
Study officials:
affiliation: OhioHealth
name: Christopher Hyer, DPM
role: PRINCIPAL_INVESTIGATOR
References: