Pericapsular Exparel for Pain Relief in Bunionectomy and Related Procedures



Status:Terminated
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:7/27/2016
Start Date:July 2015
End Date:July 2016

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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).

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.

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
We found this trial at
2
sites
111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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Westerville, Ohio 43082
Phone: 614-895-2424
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