NCT04272086

Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fibroid Uterus

Interventions

Type	Name	Description
DRUG	Bupivacaine	0.25%
DRUG	Bupivacaine liposome	10mL
DRUG	normal saline	10ml

Timeline

• Start date: 2020-11-09
• Primary completion: 2025-10-28
• Completion: 2025-10-28
• First posted: 2020-02-17
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study