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Completed

NCT Number: NCT03006042

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

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.

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Key information

Conditions

Anesthesia Adverse Effect Cesarean Section Transversus Abdominis Plane Block

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine

Drug

Primary outcomes

  1. Total venous plasma concentration of BPV

    Time frame: Immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and 1440 minutes after both TAP blocks.

Secondary outcomes

  1. corrected QT interval

    Time frame: at 1, 2, 3 and 4 hours after TAP blocks

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
First posted
Dec 30, 2016
Registry last updated
Dec 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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