RECRUITING

Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: a Prospective Randomized Control Trial

Quick Facts

Study Start:2020-11-09
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04272086

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.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Not pregnant
  2. * Weight over 50kg presenting for open myomectomy
  3. * No history of allergy to any study medication
  4. * No history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas
  5. * No history of drug or alcohol use or abuse disorder or pre-existing liver disease.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

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

Principal Investigator

Daniel Katz, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Daniel Katz, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2020-11-09
Study Completion Date2025-12

Study Record Updates

Study Start Date2020-11-09
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Fibroid uterus
  • Myomectomy
  • Abdominal myomectomy

Additional Relevant MeSH Terms

  • Fibroid Uterus