Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures

NCT02499575 — Not applicable, Terminated, 2 participants, OhioHealth

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

Registry	NCT02499575
Status	Terminated - Logistical issues prevent efficient enrollment
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, supportive care
Enrollment	2 (Actual)
Sponsor	OhioHealth (Other)
Conditions	Bunion, Hallux Rigidus
Interventions	0.5% ropivacaine, Exparel (Drug)
Dates	start 2015-07-01, primary completion 2016-01-01, completion 2016-07-01, first posted 2015-07-16, last updated 2017-05-17
Locations	2 sites in United States

-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).

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Regional Block	Active comparator	Drug: 0.5% ropivacaine	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).
Regional Block Plus Exparel	Experimental	Drug: 0.5% ropivacaine; Drug: 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.

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

+Outcome measures

Primary outcomes

Opioid Use as Measured by Questionnaire [Daily through the third day (72 hours) post-surgery]: Compare time to first opioid use over 72 hours between groups
Total Opioid Use as Measured by Questionnaire [Daily through the third day (72 hours) post-surgery]: Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.

Secondary outcomes

Pain Relief Measured by Defense and Veterans Pain Scale [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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Posted results

Participant flow

Milestone	Regional Block	Regional Block Plus Exparel
Started	1	1
Completed	1	0
Not completed	0	1

Outcome results

Opioid Use as Measured by Questionnaire (Primary), Number, hours: Regional Block 6; Regional Block Plus Exparel
Total Opioid Use as Measured by Questionnaire (Primary), Number, morphine equivalents: Regional Block 18; Regional Block Plus Exparel
Pain Relief Measured by Defense and Veterans Pain Scale (Secondary), Number, units on scale of 0 -10: Regional Block 0; Regional Block Plus Exparel

Adverse events

Time frame: up to 30 days

Arm	Deaths	Serious adverse events	Other adverse events
Regional Block	0	0/1 (0.0%)	0/1 (0.0%)
Regional Block Plus Exparel	0	0/1 (0.0%)	0/1 (0.0%)

+Locations (2)

Facility	City	Country	Status
Grant Medical Center	Columbus, Ohio	United States
Orthopedic Foot and Ankle Center	Westerville, Ohio	United States

+Investigators

Christopher Hyer, DPM, Principal investigator, OhioHealth