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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03006042
Other study ID # UTEM BPV
Secondary ID
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. completion date
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


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
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