Anesthesia Clinical Trial
Official title:
Pharmacokinetics of Bupivacaine Following Bilateral Ultrasound-guided Transversus Abdominis Plane Block for Cesarean Section
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 |
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 |
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.
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Tunis El Manar |
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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