Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

NCT ID: NCT02499575

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-07-31

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.

Conditions

Bunion; Hallux Rigidus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Regional Block

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).

Group Type: ACTIVE_COMPARATOR

0.5% ropivacaine

Intervention Type: DRUG

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

Regional Block Plus 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.

Group Type: EXPERIMENTAL

0.5% ropivacaine

Intervention Type: DRUG

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

Exparel

Intervention Type: DRUG

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

Interventions

0.5% ropivacaine

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

Intervention Type: DRUG

Exparel

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

Intervention Type: DRUG

Other Intervention Names

ropivacaine; Liposomal bupivacaine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OhioHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Hyer, DPM

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Locations

Grant Medical Center

Columbus, Ohio, United States

Orthopedic Foot and Ankle Center

Westerville, Ohio, United States

Countries

United States

Other Identifiers

OH2-15-0005

Identifier Type: -

Identifier Source: org_study_id