Clinical trial NCT04751344: Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery
Official title: RANDOMIZED CONTROLLED TRIAL COMPARING LIPOSOMAL BUPIVACAINE VERSUS BUPIVACAINE HCL FOR POSTOPERATIVE MANAGEMENT OF FOREFOOT SURGERY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liposomal Bupivacaine
Postoperative Pain
Forefoot Surgery
Opioid Use
Bunion
Lead sponsor: Lenox Hill Hospital
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 room the subject will be entered into the randomization system which will specify whether to inject 10cc (5mg/mL) of bupivacaine HCl or 8cc (13.3 mg/mL) liposomal bupivacaine, both considered routine care procedure. Thereafter, postoperative pain will be assessed and measured using a Visual Analog Scale (VAS) scoring scale post-operatively at 2 hours, 24 hours, 48 hours and 72 hours. In addition, the amount of oral morphine equivalents (OME) required postoperatively and time to first use of OME will be measured. Our hypothesis is that patients who received liposomal bupivacaine will have less post-operative pain and require less OMEs.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Effect of liposomal bupivacaine on postoperative pain control
timeFrame: The study will last 72 hours after the elective procedure.
Secondary outcomes:
measure: Effect of liposomal bupivacaine on opioid use
timeFrame: The study will last 72 hours after the elective procedure.
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Eyes Ears and Throat Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Elliot Hershman, MD
role: PRINCIPAL_INVESTIGATOR
References: