Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

OhioHealth

Status: Terminated

Conditions: Hallux Rigidus; Bunion

Treatments: Drug: Exparel; Drug: 0.5% ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02499575

OH2-15-0005

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Regional Block

Active Comparator group

Description:

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).

Treatment:

Drug: 0.5% ropivacaine

Regional Block Plus Exparel

Experimental group

Description:

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.

Treatment:

Drug: 0.5% ropivacaine

Drug: Exparel