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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006042
• Other study ID #: UTEM BPV
• Status: Completed
• Phase: N/A
• First received: December 20, 2016
• Last updated: December 26, 2016
• Start date: November 2014

Study information

• Verified date: December 2016
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adverse Effect
• Anesthesia
• Cesarean Section
• Transversus Abdominis Plane Block

Intervention

Drug:
• Bupivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	corrected QT interval		at 1, 2, 3 and 4 hours after TAP blocks	No