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 |
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).
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.
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
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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