<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03006042</url>
  </required_header>
  <id_info>
    <org_study_id>UTEM BPV</org_study_id>
    <nct_id>NCT03006042</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of BPV Following Bilateral US-guided TAP Block for C-section</brief_title>
  <official_title>Pharmacokinetics of Bupivacaine Following Bilateral Ultrasound-guided Transversus Abdominis Plane Block for Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Tunis El Manar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Tunis El Manar</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The transversus abdominis plane block (TAP block) is an effective method of postoperative&#xD;
      pain management after cesarean section (C-section). Up to now, there are no data available&#xD;
      about bupivacaine (BPV) plasma levels after TAP block in adults. In the current study, the&#xD;
      investigators aimed to assess BPV pharmacokinetic parameters after ultrasound-guided TAP&#xD;
      block using BPV in parturients undergoing C-section and to report its effects on corrected QT&#xD;
      interval.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators led a prospective observational study in pregnant women undergoing elective&#xD;
      C-section under spinal anesthesia (SA) using 10 mg of hyperbaric BPV. After surgery, they&#xD;
      received bilateral ultrasound-guided TAP block with 50 mg of BPV in each side. Venous blood&#xD;
      samples were collected immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and&#xD;
      1440 minutes after both TAP blocks. The investigators used high performance liquid&#xD;
      chromatography (HPLC) to measure BPV total plasma concentrations. Mean BPV area under the&#xD;
      curve (AUC) was calculated from 0 to 24 hours according to the linear trapezoidal rule. Mean&#xD;
      peak of total BPV plasma concentration (Cmax) and time to reach the peak (Tmax) were&#xD;
      recorded. Electrocardiographic (ECG) recordings were also repeated at 1, 2, 3 and 4 hours to&#xD;
      investigate the effect of BPV on corrected QT (QTc) intervals. Data were computed using SPSS&#xD;
      20®. Quantitative data were expressed as means ± SD. Qualitative data were expressed as&#xD;
      percentages.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total venous plasma concentration of BPV</measure>
    <time_frame>Immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and 1440 minutes after both TAP blocks.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>corrected QT interval</measure>
    <time_frame>at 1, 2, 3 and 4 hours after TAP blocks</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">17</enrollment>
  <condition>Anesthesia</condition>
  <condition>Adverse Effect</condition>
  <condition>Cesarean Section</condition>
  <condition>Transversus Abdominis Plane Block</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        After obtaining approval by the institute ethics committee and having written informed&#xD;
        consent signed on the day of surgery, 17 American Society of Anesthesiologists (ASA)&#xD;
        physical status I-II pregnant women aged between 20 and 40 years scheduled for elective&#xD;
        C-section with Pfannenstiel incision, under SA, were enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ASA physical status I-II pregnant women scheduled for elective C-section with Pfannenstiel&#xD;
        incision under Spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA physical status &gt; II,&#xD;
&#xD;
          -  known allergy to local anesthetics,&#xD;
&#xD;
          -  body mass index (BMI) more than 40 kg/m²,&#xD;
&#xD;
          -  coagulation disorders,&#xD;
&#xD;
          -  neurologic or neuromuscular disease,&#xD;
&#xD;
          -  significant liver or renal dysfunction,&#xD;
&#xD;
          -  electrolyte disturbances,&#xD;
&#xD;
          -  heart arrhythmias,&#xD;
&#xD;
          -  corrected QT (QTc) interval&gt; 0.47s&#xD;
&#xD;
          -  patients taking drugs that may prolong QT interval.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 26, 2016</last_update_submitted>
  <last_update_submitted_qc>December 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Tunis El Manar</investigator_affiliation>
    <investigator_full_name>Ben marzouk Sofiene</investigator_full_name>
    <investigator_title>MD, assistant professor</investigator_title>
  </responsible_party>
  <keyword>bupivacaine</keyword>
  <keyword>local anaesthetics</keyword>
  <keyword>cesarean section</keyword>
  <keyword>transversus abdominis plane block</keyword>
  <keyword>toxicity</keyword>
  <keyword>ultrasound guidance</keyword>
  <keyword>QTc interval</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03006042
org study id: UTEM BPV
nct id: NCT03006042
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Total venous plasma concentration of BPV
time frame: Immediately before and at 10, 30, 45, 60, 90, 120, 180, 240, 720 and 1440 minutes after both TAP blocks.
measure: corrected QT interval
time frame: at 1, 2, 3 and 4 hours after TAP blocks
intervention type: Drug
intervention name: Bupivacaine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University Tunis El Manar
investigator full name: Ben marzouk Sofiene
investigator title: MD, assistant professor
mesh term: Bupivacaine
sharing ipd: No