Icahn School of Medicine at Mount Sinai
Daniel Katz
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.
Fibroid Uterus
Bupivacaine
Bupivacaine liposome
normal saline
PHASE4
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 |
| Estimated Enrollment : | 140 participants |
| Masking : | QUADRUPLE |
| 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. |
| Primary Purpose : | TREATMENT |
| Official Title : | Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: a Prospective Randomized Control Trial |
| Actual Study Start Date : | 2020-11-09 |
| Estimated Primary Completion Date : | 2025-09 |
| Estimated Study Completion Date : | 2025-12 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 64 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029