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Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Recruiting
CT.gov ID
NCT04272086
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
25.7
Anticipated Duration (Months)
5.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Anticipated 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 tapDouble 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
Actual Study Start Date :
Nov 9, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Morphine Equivalents at 72 Hours [72 hours]

    Total cumulative opiates consumed converted to morphine equivalents

Secondary Outcome Measures

  1. Morphine Equivalents at 96 Hours [96 hours]

    Total cumulative opiates consumed converted to morphine equivalents

  2. Morphine Equivalents at 48 Hours [48 hours]

    Total cumulative opiates consumed converted to morphine equivalents

  3. Opiate Sparing Criteria at 72 hours [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 [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 [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 [96 hours]

    Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Icahn School of Medicine at Mount Sinai New York New York United States 10029

Sponsors and Collaborators

  • Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Daniel Katz, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Feb 17, 2020
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daniel Katz, Associate Professor, Icahn School of Medicine at Mount Sinai
Fibroid uterus
Myomectomy
Abdominal myomectomy
Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Bupivacaine

Study Results

No Results Posted as of Oct 7, 2021