- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04272086
Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy
August 14, 2023 updated by: Daniel Katz, Icahn School of Medicine at Mount Sinai
Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial
The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine.
The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP.
Blocks will occur post induction and pre incision.
Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection.
The entire care team and the patient will be blinded.
A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery.
Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.
Study Type
Interventional
Enrollment (Estimated)
140
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: Daniel Katz, MD
- Phone Number: 212-241-7475
- Email: daniel.katz@mountsinai.org
Study Contact Backup
- Name: James Leader
- Phone Number: 212-241-7475
- Email: james.leader@mountsinai.org
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Recruiting
- Icahn School of Medicine at Mount Sinai
-
Contact:
- Daniel Katz, MD
- Phone Number: 212-241-7475
- Email: daniel.katz@mountsinai.org
-
-
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 to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Not pregnant
- Weight over 50kg presenting for open myomectomy
- No history of allergy to any study medication
- No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas
- No history of drug or alcohol use or abuse disorder or pre-existing liver disease.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Bupivacaine TAP
TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side
|
0.25%
10ml
|
Experimental: Liposomal bupivacaine TAP
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
|
0.25%
10ml
10mL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine Equivalents at 72 Hours
Time Frame: 72 hours
|
Total cumulative opiates consumed converted to morphine equivalents
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine Equivalents at 96 Hours
Time Frame: 96 hours
|
Total cumulative opiates consumed converted to morphine equivalents
|
96 hours
|
Morphine Equivalents at 48 Hours
Time Frame: 48 hours
|
Total cumulative opiates consumed converted to morphine equivalents
|
48 hours
|
Opiate Sparing Criteria at 72 hours
Time Frame: 72 hours
|
Composite score of minimal opiate dose and additionally scores of 0 on questions 2,3,4,5,6 on OBAS scoring scale. Overall Benefit of Analgesic Score (OBAS) scoring scale -total scale from 0-20, low score indicates high benefit. |
72 hours
|
Quality of Recovery at 48 hours
Time Frame: 48 hours
|
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
|
48 hours
|
Quality of Recovery at 72 hours
Time Frame: 72 hours
|
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
|
72 hours
|
Area under the curve pain scale at 96 hours
Time Frame: 96 hours
|
Sum of pain scores at 24, 48, 72, and 96 hours.
Pain scale from 0-10, with higher score indicating worst pain.
|
96 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel Katz, MD, Icahn School of Medicine at Mount Sinai
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)
November 9, 2020
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
February 13, 2020
First Submitted That Met QC Criteria
February 14, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Connective Tissue Diseases
- Neoplasms, Connective Tissue
- Neoplasms, Muscle Tissue
- Leiomyoma
- Myofibroma
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- GCO 19-1807
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
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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