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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Morphine Equivalents at 72 Hours
Total cumulative opiates consumed converted to morphine equivalents
Time frame: 72 hours
Morphine Equivalents at 96 Hours
Total cumulative opiates consumed converted to morphine equivalents
Time frame: 96 hours
Morphine Equivalents at 48 Hours
Total cumulative opiates consumed converted to morphine equivalents
Time frame: 48 hours
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.
Time frame: 72 hours
Quality of Recovery at 48 hours
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
Time frame: 48 hours
Quality of Recovery at 72 hours
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
Time frame: 72 hours
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.
Time frame: 96 hours
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