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The Effect of Some Parturients' Characteristics on Sensory Block Level After Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT03164096
Recruitment Status : Unknown
Verified January 2018 by Ghada Mohammed AboelFadl, Assiut University.
Recruitment status was:  Recruiting
First Posted : May 23, 2017
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ghada Mohammed AboelFadl, Assiut University

Tracking Information
First Submitted Date  ICMJE May 20, 2017
First Posted Date  ICMJE May 23, 2017
Last Update Posted Date March 29, 2018
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • sensory level [ Time Frame: from allocation until 24 hours post-operative ]
    effect of different parameters in sensory level
  • motor block [ Time Frame: from allocation until 24 hours post-operative ]
    effect of different parameters in motor level
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • hypotension [ Time Frame: from allocation until 24 hours post-operative ]
    incidence of hypotension after spinal anesthesia
  • vasopressor consumption [ Time Frame: from allocation until 24 hours post-operative ]
    total dose of ephedrine consumed by the patients
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Some Parturients' Characteristics on Sensory Block Level After Spinal Anesthesia
Official Title  ICMJE The Effect of Body Mass Index, Intra-abdominal Pressure, Abdominal Girth and Waist Circumference on Sensory Block Level After Single-shot Spinal Anesthesia for Cesarean Section
Brief Summary Although the exact mechanism remains unknown, the association of pregnancy and decreased local anesthetic requirement is clear. demonstrated that more local anesthetic is required for cesarean section under combined spinal-epidural anesthesia in preterm compared with term patients.
Detailed Description

However, in pregnant patients, venous engorgement is prominent in the supine but not the lateral position, which suggests direct compression of the inferior vena cava by the gravid uterus. Second, an increase in intraabdominal pressure may affect the retroperitoneal area and may cause inward movement of soft tissue in the intervertebral foramina. Recent magnetic resonance imaging studies in pregnant patients, although without intraabdominal pressure measurements, suggested the latter because they showed limited contact of engorged veins along the dural sac which may therefore not be responsible for compression of the dura.

If elevated intraabdominal pressure contributes to high anesthetic spread during pregnancy, one would expect a relationship between intraabdominal pressure and maximum sensory block level.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
evaluating relationship of sensory level and other patient factors
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Anesthesia, Obstetrical
Intervention  ICMJE Drug: Bupivacaine Hydrochloride
intrathecal bupivacaine will be used for spinal anesthesia in obstetric patients undergoing C-section
Other Name: intrathecal bupivacaine
Study Arms  ICMJE Experimental: intrathecal bupivacaine
intrathecal bupivacaine hydrochloride 0.5%,12.5mg
Intervention: Drug: Bupivacaine Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 22, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 10, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult female partner
  • aged 18 to 40 years.
  • scheduled for elective cesarean section.

Exclusion Criteria:

  • Patients with coagulopathy or under anti-coagulation therapy.
  • Gastrointestinal disease,
  • motion sickness.
  • diabetes mellitus.
  • Patients with preeclampsia,
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03164096
Other Study ID Numbers  ICMJE obstanesth
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ghada Mohammed AboelFadl, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP