Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Fibroid Uterus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04272086
• Other study ID #: GCO 19-1807
• Status: Recruiting
• Phase: Phase 4
• Start date: November 9, 2020
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Daniel Katz, MD
• Phone: 212-241-7475
• Email: daniel.katz[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibroid Uterus
• Leiomyoma

Intervention

Drug:
• Bupivacaine
0.25%
• Bupivacaine liposome
10mL
• normal saline
10ml

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Equivalents at 72 Hours	Total cumulative opiates consumed converted to morphine equivalents	72 hours
Secondary	Morphine Equivalents at 96 Hours	Total cumulative opiates consumed converted to morphine equivalents	96 hours
Secondary	Morphine Equivalents at 48 Hours	Total cumulative opiates consumed converted to morphine equivalents	48 hours
Secondary	Opiate Sparing Criteria at 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.	72 hours
Secondary	Quality of Recovery at 48 hours	15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.	48 hours
Secondary	Quality of Recovery at 72 hours	15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.	72 hours
Secondary	Area under the curve pain scale at 96 hours	Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain.	96 hours