Clincosm LogoSign in Get a demo

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

Sponsor
University Tunis El Manar (Other)
Overall Status
Completed
CT.gov ID
NCT03006042
Collaborator
(none)
17
Enrollment

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Actual Enrollment :
17 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Pharmacokinetics of Bupivacaine Following Bilateral Ultrasound-guided Transversus Abdominis Plane Block for Cesarean Section
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
May 1, 2015

Outcome Measures

Primary Outcome Measures

  1. 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

  1. corrected QT interval [at 1, 2, 3 and 4 hours after TAP blocks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Tunis El Manar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ben marzouk Sofiene, MD, assistant professor, University Tunis El Manar
ClinicalTrials.gov Identifier:
NCT03006042
Other Study ID Numbers:
  • UTEM BPV
First Posted:
Dec 30, 2016
Last Update Posted:
Dec 30, 2016
Last Verified:
Dec 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Ben marzouk Sofiene, MD, assistant professor, University Tunis El Manar
bupivacaine
local anaesthetics
cesarean section
transversus abdominis plane block
toxicity
ultrasound guidance
QTc interval
Additional relevant MeSH terms:
Bupivacaine

Study Results

No Results Posted as of Dec 30, 2016