Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bunion, Hallux Rigidus

Intervention / Treatment
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* Drug: 0.5% ropivacaine
* Drug: Exparel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regional Block<br>Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg). | Drug: 0.5% ropivacaine<br>* Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine<br>* Other names: ropivacaine;|
| Experimental: Regional Block Plus Exparel<br>Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations. | Drug: 0.5% ropivacaine<br>* Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine<br>* Other names: ropivacaine;Drug: Exparel<br>* 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)<br>* Other names: Liposomal bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use as Measured by Questionnaire | Compare time to first opioid use over 72 hours between groups | 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. | Daily through the third day (72 hours) post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exparel, bupivacaine, Hallux valgus deformity, bunionectomy