Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

Not Applicable

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Regional Block Plus Exparel	0.5% ropivacaine	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.
Regional Block	0.5% ropivacaine	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).
Regional Block Plus Exparel	Exparel	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.

Primary Outcome Measures

Name	Time	Method
Opioid Use as Measured by Questionnaire	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	Daily through the third day (72 hours) post-surgery	Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.

Secondary Outcome Measures

Name	Time	Method
Pain Relief Measured by Defense and Veterans Pain Scale	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