Pharmacokinetics of Levobupivacaine After Cesarean Section

PHASE4CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

December 15, 2016

Primary Completion Date

February 15, 2017

Study Completion Date

February 15, 2017

Conditions
Pain, Postoperative
Interventions
DRUG

Levobupivacaine

After the block procedure, 2 ml blood samples will be taken in defined times to determine the plasma blood levels of levobupivacaine.

PROCEDURE

Spinal anesthesia

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.

PROCEDURE

Peripheral vein canulation

An intravenous (18-gauge) catheter will be placed under local anesthesia for co hydration and a second IV catheter for venous sampling

PROCEDURE

Ultrasonography

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.

DEVICE

Holter

A portable 12-lead Holter (NorthEast Monitoring®, Boston, USA) will record continuously the electrocardiogram (ECG) after the TAP block, for 24 hrs.

Trial Locations (1)

8330024

Hospital Clinico Universidad Catolica de Chile, Santiago

All Listed Sponsors
lead

Pontificia Universidad Catolica de Chile

OTHER

NCT02852720 - Pharmacokinetics of Levobupivacaine After Cesarean Section | Biotech Hunter | Biotech Hunter