drugset / Trial / NCT02519023

TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy

NCT02519023

Phase 4 Completed 87 enrolled University of Minnesota
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. To augment this pain there are many different analgesic techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP) block is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet different analgesic approach is that of direct injection of local anesthetic into the incision by the surgeon during or just after surgical procedures. These two approaches have both been proven to decrease post-operative pain in patients for many procedures, but never compared to one another.

Timeline

Start
2016-07
Primary completion
2017-05
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 5 ml Other
Comparator Bupivacaine Other / unclassified 20 ml Other
Background Acetaminophen Small molecule 1 g
Background Epinephrine Other / unclassified Other
Background Ibuprofen Small molecule 800 mg
Background Oxycodone Other / unclassified 5 mg
Background Oxycodone Other / unclassified 10 mg

Indications

No indication recorded.