Status:
UNKNOWN
Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery
Lead Sponsor:
Alexandra Black
Conditions:
Liposomal Bupivacaine
Postoperative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Prospective, randomized, controlled single-blinded trial comparing liposomal bupivacaine with bupivacaine HCl for postoperative management. Upon completion of the forefoot procedure in the operative r...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, greater than 18 years of age
- ASA Class I or II
- Ability to take oral medication in order to assess the patient's opioid regimen postoperatively
- Forefoot surgery, including bunionectomy +/- digital surgery
- For females of reproductive potential: hCG levels will be determined during the pre-operative period. Females of childbearing age require a hCG level below 5mIU/mL in order to participate in the study. hCG levels above 25 mIU/mL is considered positive for pregnancy and, as a result, the patient will not be considered eligible for inclusion in the study
Exclusion
- Chronic users of opioids, use for greater than 14 days in the last 3 months or nonopioid pain medications for more than 5 times per week
- Prescription for SSRIs, gabapentin, duloxetine within 3 days of surgery
- Systemic glucocorticoids within 1 month of study enrollment
- History of hepatitis
- History of peripheral vascular disease
- History of diabetes mellitus type 1 or 2
- Pregnancy or lactation
- Allergic to opioids
- Known allergic reactions to components of the bupivacaine injectable or other amide anesthetics; the allergen may involve preservative compounds such as methylparaben used in the preparation of amide-type agents are metabolized to PABA
- BMI \> 40
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04751344
Start Date
June 16 2020
End Date
June 1 2022
Last Update
February 25 2021
Active Locations (1)
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1
Manhattan Eyes Ears and Throat Hospital
New York, New York, United States, 10065