Pharmacokinetics of BPV Following Bilateral US-guided TAP Block for C-section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pharmacokinetics of Bupivacaine Following Bilateral Ultrasound-guided Transversus Abdominis Plane Block for Cesarean Section

Conditions
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Anesthesia, Adverse Effect, Cesarean Section, Transversus Abdominis Plane Block

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-II pregnant women scheduled for elective C-section with Pfannenstiel incision under Spinal anesthesia Exclusion Criteria: ASA physical status > II, known allergy to local anesthetics, body mass index (BMI) more than 40 kg/m², coagulation disorders, neurologic or neuromuscular disease, significant liver or renal dysfunction, electrolyte disturbances, heart arrhythmias, corrected QT (QTc) interval> 0.47s patients taking drugs that may prolong QT interval.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bupivacaine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total venous plasma concentration of BPV |  | Immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and 1440 minutes after both TAP blocks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corrected QT interval |  | at 1, 2, 3 and 4 hours after TAP blocks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bupivacaine, local anaesthetics, cesarean section, transversus abdominis plane block, toxicity, ultrasound guidance, QTc interval