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

Completed

• Conditions: Anesthesia; Adverse Effect; Cesarean Section; Transversus Abdominis Plane Block

• Registration Number: NCT03006042
• Lead Sponsor: University Tunis El Manar

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-05
• Status Verified: 2016-12
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-26
• Last Update Submitted: 2016-12-26
• Study First Posted: 2016-12-30
• Last Update Posted: 2016-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

ASA physical status I-II pregnant women scheduled for elective C-section with Pfannenstiel incision under Spinal anesthesia

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
corrected QT interval	at 1, 2, 3 and 4 hours after TAP blocks