Icahn School of Medicine at Mount Sinai
New York, 10029, United States
NCT Number: NCT04272086
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.
Looking for future studies?
Notify Me18 year–64 year
Female
Interventional
Phase 4
New York, 10029, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
0.25%
10mL
10ml
Time frame: 72 hours
Total cumulative opiates consumed converted to morphine equivalents
Time frame: 96 hours
Total cumulative opiates consumed converted to morphine equivalents
Time frame: 48 hours
Total cumulative opiates consumed converted to morphine equivalents
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.
Time frame: 48 hours
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
Time frame: 72 hours
15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.
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.
Icahn School of Medicine at Mount Sinai
Other
Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07365969
Fibroid Uterus, Hysterectomy
Cairo, Egypt
View Trial DetailsNCT06429163
Fibroid Uterus, Leiomyoma
Saint Petersburg, Russia
View Trial DetailsNCT04145518
Dysmenorrhea, Dysmenorrhea (Disorder)
Evanston, Illinois, United States
View Trial DetailsNCT04434066
Abnormal Uterine Bleeding, Endometriosis
Dallas, Texas, United States
View Trial Details