At a glance
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Pharmacokinetics of Levobupivacaine and Epinephrine for Transversus Abdominis Plane (TAP) Block for Cesarean Section Postoperative Analgesia
In Brief
A Phase 4 clinical trial evaluating Levobupivacaine, Spinal anesthesia, and 3 other interventions for Pain, Postoperative. Completed, enrolled 12 participants across 1 site.
Detailed Summary
Transversus abdominis plane (TAP) block provides effective analgesia and is now a standard of care for analgesia after cesarean section. There is no information on levobupivacaine pharmacokinetics post TAP after pregnancy. Objective: Generate a pharmacokinetic levobupivacaine model and its effect on the electrocardiogram (ECG). Method: The investigators will study 12 healthy term pregnant patients, scheduled for elective cesarean section under spinal anesthesia. A bilateral TAP block is performed with 20 ml 0.25% levobupivacaine with epinephrine 5 ug/ml. Sensory block will be assessed at 1-2-6 and 12 hours post puncture. 2 ml of venous blood will be obtained at 2-5-10-30-45-60-90 and 180 minutes. With a Holter machine we will study the effect of levobupivacaine plasma levels and the QTc changes. Expected results: 1) Plasma levobupivacaine levels; 2) Changes in QTc .
Study Details
Timeline
Interventions
After the block procedure, 2 ml blood samples will be taken in defined times to determine the plasma blood levels of levobupivacaine.
Spinal anesthesia in the L3-L4 or L4-L5 interspace with hyperbaric bupivacaine 0,75% 1,4 ml plus 20 ug fentanyl to achieve a bilateral anesthetic level of T4 determined by pinprick.
An intravenous (18-gauge) catheter will be placed under local anesthesia for co hydration and a second IV catheter for venous sampling
TAP blocks will be performed using a ultrasound Sonosite M-Turbo US machine (Sonosite Inc, Washington) with an L38x 10-5 megahertz (MHz), 38-mm broadband linear array probe.
A portable 12-lead Holter (NorthEast Monitoring®, Boston, USA) will record continuously the electrocardiogram (ECG) after the TAP block, for 24 hrs.