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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

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.

Conditions

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Anesthesia Adverse Effect Cesarean Section Transversus Abdominis Plane Block

Keywords

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bupivacaine local anaesthetics cesarean section transversus abdominis plane block toxicity ultrasound guidance QTc interval

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Bupivacaine

Intervention Type DRUG

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Ben marzouk Sofiene

MD, assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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UTEM BPV

Identifier Type: -

Identifier Source: org_study_id