Recruiting

Liposomal Bupivacaine vs. Bupivacaine

Sponsor:

Alexandra Black

Code:

NCT04751344

Conditions

Liposomal Bupivacaine

Postoperative Pain

Forefoot Surgery

Opioid Use

Bunion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Liposomal bupivacaine

Bupivacaine HCl

Study Details

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.

Conditions

Liposomal Bupivacaine

Postoperative Pain

Forefoot Surgery

Opioid Use

Bunion

Study ID

NCT04751344

Start date

Jun 16, 2020

Status verified date

Feb, 2021

Completion date

Jun, 2022

Anticipated

Primary completion date

Jun, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Liposomal Bupivacaine

The liposomal bupivacaine study arm will receive 8cc (13.3 mg/mL) liposomal bupivacaine via intravenous route at the completion of the procedure.

active comparator: Bupivacaine HCl

The Bupivacaine HCl study arm will receive 10cc (5mg/mL) of bupivacaine HCl via intravenous route at the completion of the procedure.

Interventions

Liposomal bupivacaine

Prior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 8cc of liposomal bupivacaine (13.3mg/mL) will be injected around the surgical site.

Bupivacaine HCl

Prior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 10cc of bupivacaine HCl (5mg/mL) will be injected around the surgical site.

Primary outcome measure

  • Effect of liposomal bupivacaine on postoperative pain control [ Time Frame: The study will last 72 hours after the elective procedure. ]

Central Contacts and Locations

Central contacts

Alexandra Black, DPM

212-570-9300alextblack@gmail.com

Sariah Ramoutarpersaud, MD

718-869-3517sramoutarp@northwell.edu

Locations

Manhattan Eyes Ears and Throat Hospital

Recruiting

New York, New York, United States, 10065

More Information

Sponsor

Alexandra Black

Last update posted

Feb 25, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alexandra Black on 2021-02-25.