Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

Hallux Rigidus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02499575
• Other study ID #: OH2-15-0005
• Status: Terminated
• Phase: N/A
• First received: July 2, 2015
• Last updated: July 25, 2016
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bunion
• Hallux Limitus
• Hallux Rigidus
• Hallux Valgus

Intervention

Drug:
• 0.5% ropivacaine
Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
• Exparel
106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)

Locations

Country	Name	City	State
United States	Grant Medical Center	Columbus	Ohio
United States	Orthopedic Foot and Ankle Center	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
OhioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Use as Measured by Questionnaire	Compare time to first opioid use and total opioid use (reported as total morphine equivalents) over 72 hours between groups	Daily through the third day (72 hours) post-surgery	No
Secondary	Pain Relief Measured by Defense and Veterans Pain Scale	Evaluate patient-reported pain scores (scale of 1-10) 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)	No