Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Mount Sinai Health System

Status and phase: Completed; Phase 4

Conditions: Fibroid Uterus

Treatments: Drug: normal saline; Drug: Bupivacaine; Drug: Bupivacaine liposome

Study type: Interventional

Funder types: Other

Identifiers

NCT04272086

GCO 19-1807

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Bupivacaine TAP

Placebo Comparator group

Description:

TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side

Treatment:

Drug: Bupivacaine

Drug: normal saline

Liposomal bupivacaine TAP

Experimental group

Description:

TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side

Treatment:

Drug: Bupivacaine liposome

Drug: Bupivacaine

Drug: normal saline