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Spots Global Cancer Trial Database for Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

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Trial Identification

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 ID: NCT04272086

Conditions

Fibroid Uterus

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

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

Contact Details

Name: Daniel Katz, MD

Affiliation: Icahn School of Medicine at Mount Sinai

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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