- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04751344
Liposomal Bupivacaine Versus Bupivacaine Plain for Operative Pain Management of Forefoot Surgery
February 23, 2021 updated by: Alexandra Black
RANDOMIZED CONTROLLED TRIAL COMPARING LIPOSOMAL BUPIVACAINE VERSUS BUPIVACAINE HCL FOR POSTOPERATIVE MANAGEMENT OF FOREFOOT SURGERY
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexandra Black, DPM
- Phone Number: 212-570-9300
- Email: alextblack@gmail.com
Study Contact Backup
- Name: Sariah Ramoutarpersaud, MD
- Phone Number: 718-869-3517
- Email: sramoutarp@northwell.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Manhattan Eyes Ears and Throat Hospital
-
Contact:
- Elliot Hershman, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
|
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of liposomal bupivacaine on postoperative pain control
Time Frame: The study will last 72 hours after the elective procedure.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of liposomal bupivacaine on opioid use
Time Frame: The study will last 72 hours after the elective procedure.
|
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
|
The study will last 72 hours after the elective procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elliot Hershman, MD, Northwell Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 16, 2020
Primary Completion (ANTICIPATED)
June 1, 2022
Study Completion (ANTICIPATED)
June 1, 2022
Study Registration Dates
First Submitted
February 5, 2021
First Submitted That Met QC Criteria
February 8, 2021
First Posted (ACTUAL)
February 12, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 25, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Foot Deformities
- Foot Deformities, Acquired
- Pain, Postoperative
- Bunion
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- 101719
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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