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Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04272086
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Daniel Katz, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Fibroid Uterus Drug: Bupivacaine Drug: Bupivacaine liposome Drug: normal saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids

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
Drug: Bupivacaine
0.25%

Drug: normal saline
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
Drug: Bupivacaine
0.25%

Drug: Bupivacaine liposome
10mL

Drug: normal saline
10ml




Primary Outcome Measures :
  1. Morphine Equivalents at 72 Hours [ Time Frame: 72 hours ]
    Total cumulative opiates consumed converted to morphine equivalents


Secondary Outcome Measures :
  1. Morphine Equivalents at 96 Hours [ Time Frame: 96 hours ]
    Total cumulative opiates consumed converted to morphine equivalents

  2. Morphine Equivalents at 48 Hours [ Time Frame: 48 hours ]
    Total cumulative opiates consumed converted to morphine equivalents

  3. 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.


  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women have uterine fibroids
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272086


Contacts
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Contact: Daniel Katz, MD 212-241-7475 daniel.katz@mountsinai.org
Contact: James Leader 212-241-7475 james.leader@mountsinai.org

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Contact: Daniel Katz, MD    212-241-7475    daniel.katz@mountsinai.org   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Daniel Katz, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Daniel Katz, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04272086    
Other Study ID Numbers: GCO 19-1807
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Katz, Icahn School of Medicine at Mount Sinai:
Fibroid uterus
Myomectomy
Abdominal myomectomy
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents