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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04272086
Other study ID # GCO 19-1807
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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