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

NCT04751344 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 101719
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Effect of liposomal bupivacaine on postoperative pain control

  VAS scores, which measure the intensity of pain on a scale of 1 to 10, will be collected at 2, 24, 48 and 72 hours post-operatively in order to assess therapeutic effect of local anesthetic medication for postoperative pain control.

  The study will last 72 hours after the elective procedure.

Secondary Outcomes (1)

• Effect of liposomal bupivacaine on opioid use

  The study will last 72 hours after the elective procedure.

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

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

Drug: Liposomal bupivacaine

Bupivacaine HCl

ACTIVE COMPARATOR

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

Drug: Bupivacaine HCl

Interventions

Liposomal bupivacaine 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.

Also known as: Exparel

Liposomal Bupivacaine

Bupivacaine HCl 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.

Also known as: Marcaine

Bupivacaine HCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandra Black: lead

Study Sites (1)

Manhattan Eyes Ears and Throat Hospital

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Bunion

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Elliot Hershman, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Black, DPM

CONTACT

212-570-9300; alextblack@gmail.com

Sariah Ramoutarpersaud, MD

CONTACT

718-869-3517; sramoutarp@northwell.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Data will be encrypted using BRMS
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DPM

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 12, 2021
• Study Start: June 16, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)