Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy
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|ClinicalTrials.gov Identifier: NCT04272086|
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : October 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fibroid Uterus||Drug: Bupivacaine Drug: Bupivacaine liposome Drug: normal saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap|
|Masking:||Quadruple (Participant, Care Provider, 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.|
|Official Title:||Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial|
|Estimated Study Start Date :||November 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Placebo Comparator: Bupivacaine TAP
TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side
Drug: normal saline
Experimental: Liposomal bupivacaine TAP
TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side
Drug: Bupivacaine liposome
Drug: normal saline
- Morphine Equivalents at 72 Hours [ Time Frame: 72 hours ]Total cumulative opiates consumed converted to morphine equivalents
- Morphine Equivalents at 96 Hours [ Time Frame: 96 hours ]Total cumulative opiates consumed converted to morphine equivalents
- Morphine Equivalents at 48 Hours [ Time Frame: 48 hours ]Total cumulative opiates consumed converted to morphine equivalents
- Opiate Sparing Criteria at 72 hours [ Time Frame: 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.
- Quality of Recovery at 48 hours [ Time Frame: 48 hours ]15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
- Quality of Recovery at 72 hours [ Time Frame: 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 [ Time Frame: 96 hours ]Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272086
|Contact: Daniel Katz, MDemail@example.com|
|Contact: James Leaderfirstname.lastname@example.org|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Contact: Daniel Katz, MD 212-241-7475 email@example.com|
|Principal Investigator:||Daniel Katz, MD||Icahn School of Medicine at Mount Sinai|