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Clinical Trial Summary

The transversus abdominis plane block (TAP block) is an effective method of postoperative pain management after cesarean section (C-section). Up to now, there are no data available about bupivacaine (BPV) plasma levels after TAP block in adults. In the current study, the investigators aimed to assess BPV pharmacokinetic parameters after ultrasound-guided TAP block using BPV in parturients undergoing C-section and to report its effects on corrected QT interval.


Clinical Trial Description

The investigators led a prospective observational study in pregnant women undergoing elective C-section under spinal anesthesia (SA) using 10 mg of hyperbaric BPV. After surgery, they received bilateral ultrasound-guided TAP block with 50 mg of BPV in each side. Venous blood samples were collected immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and 1440 minutes after both TAP blocks. The investigators used high performance liquid chromatography (HPLC) to measure BPV total plasma concentrations. Mean BPV area under the curve (AUC) was calculated from 0 to 24 hours according to the linear trapezoidal rule. Mean peak of total BPV plasma concentration (Cmax) and time to reach the peak (Tmax) were recorded. Electrocardiographic (ECG) recordings were also repeated at 1, 2, 3 and 4 hours to investigate the effect of BPV on corrected QT (QTc) intervals. Data were computed using SPSS 20®. Quantitative data were expressed as means ± SD. Qualitative data were expressed as percentages. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT03006042
Study type Observational
Source University Tunis El Manar
Contact
Status Completed
Phase N/A
Start date November 2014

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