Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery

NCT ID: NCT04751344

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2022-06-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Exparel; Marcaine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandra Black

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Black

DPM

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elliot Hershman, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Manhattan Eyes Ears and Throat Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexandra Black, DPM

Role: CONTACT

alextblack@gmail.com

212-570-9300

Sariah Ramoutarpersaud, MD

Role: CONTACT

sramoutarp@northwell.edu

718-869-3517

Facility Contacts

Elliot Hershman, MD

Role: primary

Other Identifiers

101719

Identifier Type: -

Identifier Source: org_study_id