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Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Primary Purpose

Fibroid Uterus

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Bupivacaine liposome
normal saline
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibroid Uterus focused on measuring Fibroid uterus, Myomectomy, Abdominal myomectomy

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Bupivacaine TAP

Liposomal bupivacaine TAP

Arm Description

TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side

TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side

Outcomes

Primary Outcome Measures

Morphine Equivalents at 72 Hours
Total cumulative opiates consumed converted to morphine equivalents

Secondary Outcome Measures

Morphine Equivalents at 96 Hours
Total cumulative opiates consumed converted to morphine equivalents
Morphine Equivalents at 48 Hours
Total cumulative opiates consumed converted to morphine equivalents
Opiate Sparing Criteria at 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.
Quality of Recovery at 48 hours
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
Quality of Recovery at 72 hours
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
Area under the curve pain scale at 96 hours
Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain.

Full Information

First Posted
February 13, 2020
Last Updated
August 14, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT04272086
Brief Title
Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy
Official Title
Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroid Uterus
Keywords
Fibroid uterus, Myomectomy, Abdominal myomectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The only people who will be unblinded are the members of the block team, who are not members of the care team nor the study team. They will open the envelopes, draw up the medications and cover the syringes with opaque paper such that no one can tell the contents.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine TAP
Arm Type
Placebo Comparator
Arm Description
TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side
Arm Title
Liposomal bupivacaine TAP
Arm Type
Experimental
Arm Description
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
0.25%
Intervention Type
Drug
Intervention Name(s)
Bupivacaine liposome
Intervention Description
10mL
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
10ml
Primary Outcome Measure Information:
Title
Morphine Equivalents at 72 Hours
Description
Total cumulative opiates consumed converted to morphine equivalents
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Morphine Equivalents at 96 Hours
Description
Total cumulative opiates consumed converted to morphine equivalents
Time Frame
96 hours
Title
Morphine Equivalents at 48 Hours
Description
Total cumulative opiates consumed converted to morphine equivalents
Time Frame
48 hours
Title
Opiate Sparing Criteria at 72 hours
Description
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.
Time Frame
72 hours
Title
Quality of Recovery at 48 hours
Description
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
Time Frame
48 hours
Title
Quality of Recovery at 72 hours
Description
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
Time Frame
72 hours
Title
Area under the curve pain scale at 96 hours
Description
Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain.
Time Frame
96 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women have uterine fibroids
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Katz, MD
Phone
212-241-7475
Email
daniel.katz@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
James Leader
Phone
212-241-7475
Email
james.leader@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Katz, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Katz, MD
Phone
212-241-7475
Email
daniel.katz@mountsinai.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

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