NCT03006042

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

December 20, 2016

Last Update Submit

December 26, 2016

Conditions

AnesthesiaAdverse EffectCesarean SectionTransversus Abdominis Plane Block

Keywords

bupivacainelocal anaestheticscesarean sectiontransversus abdominis plane blocktoxicityultrasound guidanceQTc interval

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • corrected QT interval

    at 1, 2, 3 and 4 hours after TAP blocks

Interventions

BupivacaineDRUG

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

After obtaining approval by the institute ethics committee and having written informed consent signed on the day of surgery, 17 American Society of Anesthesiologists (ASA) physical status I-II pregnant women aged between 20 and 40 years scheduled for elective C-section with Pfannenstiel incision, under SA, were enrolled in this study.

You may qualify if:

  • ASA physical status I-II pregnant women scheduled for elective C-section with Pfannenstiel incision under Spinal anesthesia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, assistant professor

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 30, 2016

Study Start

November 1, 2014

Primary Completion

May 1, 2015

Last Updated

December 30, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share