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Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

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ClinicalTrials.gov Identifier: NCT02499575
Recruitment Status : Terminated (Logistical issues prevent efficient enrollment)
First Posted : July 16, 2015
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
OhioHealth

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).

Condition or disease Intervention/treatment Phase
Bunion Hallux Rigidus Drug: 0.5% ropivacaine Drug: Exparel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Exparel Pericapsular Injection: A Prospective Evaluation of Postoperative Pain in Bunion Surgery, First Metatarsophalangeal Joint Fusion, and Cheilectomy
Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: ropivacaine

Drug: Exparel
106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
Other Name: Liposomal bupivacaine




Primary Outcome Measures :
  1. Opioid Use as Measured by Questionnaire [ Time Frame: Daily through the third day (72 hours) post-surgery ]
    Compare time to first opioid use over 72 hours between groups

  2. Total Opioid Use as Measured by Questionnaire [ Time Frame: 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 :
  1. Pain Relief Measured by Defense and Veterans Pain Scale [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499575


Locations
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United States, Ohio
Grant Medical Center
Columbus, Ohio, United States, 43215
Orthopedic Foot and Ankle Center
Westerville, Ohio, United States, 43082
Sponsors and Collaborators
OhioHealth
Investigators
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Principal Investigator: Christopher Hyer, DPM OhioHealth

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Responsible Party: OhioHealth
ClinicalTrials.gov Identifier: NCT02499575     History of Changes
Other Study ID Numbers: OH2-15-0005
First Posted: July 16, 2015    Key Record Dates
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by OhioHealth:
Exparel
bupivacaine
Hallux valgus deformity
bunionectomy

Additional relevant MeSH terms:
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Bunion
Central Nervous System Depressants
Hallux Rigidus
Hallux Limitus
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Joint Diseases
Foot Injuries
Leg Injuries
Wounds and Injuries
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents