Pharmacokinetics of Levobupivacaine After Cesarean Section

• Status: Completed
• Trial end date: 2017-02-15
• Target enrollment: 0
• Participant gender: Female

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 .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pontificia Universidad Catolica de Chile
• Treatments: Anesthetics; Bupivacaine; Epinephrine; Levobupivacaine

Criteria

Inclusion Criteria:

• Term pregnant patients

• American Society of Anesthesiologists physical status I or II, scheduled for elective cesarean section.

Exclusion Criteria:

• Allergy/sensitivity to the local anaesthetic

• Significant renal or liver dysfunction.