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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine TAP | Placebo Comparator | TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side |
|
| Liposomal bupivacaine TAP | Experimental | TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 0.25% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalents at 72 Hours | Total cumulative opiates consumed converted to morphine equivalents | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalents at 96 Hours | Total cumulative opiates consumed converted to morphine equivalents | 96 hours |
| Morphine Equivalents at 48 Hours | Total cumulative opiates consumed converted to morphine equivalents |
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Inclusion Criteria:
Only women have uterine fibroids
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Katz, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 5, 2025 | Nov 7, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap
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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.
| Bupivacaine liposome |
| Drug |
10mL |
|
| normal saline | Drug | 10ml |
|
| 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. | 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. | 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. | 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. | 96 hours |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |