Fibroid Uterus
Conditions
Keywords
Fibroid uterus, Myomectomy, Abdominal myomectomy
Brief 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.
Interventions
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The only people who will be unblinded are the members of the block team, who are not members of the care team nor the study team. They will open the envelopes, draw up the medications and cover the syringes with opaque paper such that no one can tell the contents.
Intervention model description
Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalents at 72 Hours | 72 hours | Total cumulative opiates consumed converted to morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalents at 48 Hours | 48 hours | Total cumulative opiates consumed converted to morphine equivalents |
| Opiate Sparing Criteria at 72 hours | 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. |
| Morphine Equivalents at 96 Hours | 96 hours | Total cumulative opiates consumed converted to morphine equivalents |
| Quality of Recovery at 72 hours | 72 hours | 15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery. |
| Area under the curve pain scale at 96 hours | 96 hours | Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain. |
| Quality of Recovery at 48 hours | 48 hours | 15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery. |
Countries
United States
Outcome results
None listed