Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

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

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).

Study Overview

• Status: Terminated
• Conditions: Bunion; Hallux Rigidus
• Intervention / Treatment: Drug: 0.5% ropivacaine; Drug: Exparel

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center
    • Westerville, Ohio, United States, 43082
      • Orthopedic Foot and Ankle Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Drug: 0.5% ropivacaine; Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine; Other Names: ropivacaine
Experimental: 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.	Drug: 0.5% ropivacaine; Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine; Other Names: ropivacaine; Drug: Exparel; 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl); Other Names: Liposomal bupivacaine

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: OhioHealth
• Investigators: Principal Investigator: Christopher Hyer, DPM, OhioHealth

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: April 14, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: bupivacaine; bunionectomy; Exparel; Hallux valgus deformity
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Foot Injuries; Bunion; Hallux Rigidus; Hallux Limitus; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: OH2-15-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No