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

Primary Purpose

Liposomal Bupivacaine, Postoperative Pain, Forefoot Surgery

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine HCl
Sponsored by
Alexandra Black
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Liposomal Bupivacaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Manhattan Eyes Ears and Throat HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal Bupivacaine

Bupivacaine HCl

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effect of liposomal bupivacaine on opioid use
We will quantify opioid use post-operatively by collecting data on total opioid consumption and time to first use of the opioid post-operatively by the patient

Full Information

First Posted
February 5, 2021
Last Updated
February 23, 2021
Sponsor
Alexandra Black
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1. Study Identification

Unique Protocol Identification Number
NCT04751344
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alexandra Black

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liposomal Bupivacaine, Postoperative Pain, Forefoot Surgery, Opioid Use, Bunion

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Data will be encrypted using BRMS
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
The liposomal bupivacaine study arm will receive 8cc (13.3 mg/mL) liposomal bupivacaine via intravenous route at the completion of the procedure.
Arm Title
Bupivacaine HCl
Arm Type
Active Comparator
Arm Description
The Bupivacaine HCl study arm will receive 10cc (5mg/mL) of bupivacaine HCl via intravenous route at the completion of the procedure.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
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
Intervention Name(s)
Bupivacaine HCl
Other Intervention Name(s)
Marcaine
Intervention Description
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 Information:
Title
Effect of liposomal bupivacaine on postoperative pain control
Description
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.
Time Frame
The study will last 72 hours after the elective procedure.
Secondary Outcome Measure Information:
Title
Effect of liposomal bupivacaine on opioid use
Description
We will quantify opioid use post-operatively by collecting data on total opioid consumption and time to first use of the opioid post-operatively by the patient
Time Frame
The study will last 72 hours after the elective procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Black, DPM
Phone
212-570-9300
Email
alextblack@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sariah Ramoutarpersaud, MD
Phone
718-869-3517
Email
sramoutarp@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot Hershman, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Eyes Ears and Throat Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elliot Hershman, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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