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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Anesthesia, Obstetrical Drug: Bupivacaine Hydrochloride Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Official Title: 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
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: intrathecal bupivacaine
intrathecal bupivacaine hydrochloride 0.5%,12.5mg
Drug: Bupivacaine Hydrochloride
intrathecal bupivacaine will be used for spinal anesthesia in obstetric patients undergoing C-section
Other Name: intrathecal bupivacaine




Primary Outcome Measures :
  1. sensory level [ Time Frame: from allocation until 24 hours post-operative ]
    effect of different parameters in sensory level

  2. motor block [ Time Frame: from allocation until 24 hours post-operative ]
    effect of different parameters in motor level


Secondary Outcome Measures :
  1. hypotension [ Time Frame: from allocation until 24 hours post-operative ]
    incidence of hypotension after spinal anesthesia

  2. vasopressor consumption [ Time Frame: from allocation until 24 hours post-operative ]
    total dose of ephedrine consumed by the patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164096


Locations
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Egypt
Assiut governorate Recruiting
Assiut, Egypt
Contact: Ghada M Aboelfadl, MD    01005802086    ghadafadl77@gmail.com   
Sponsors and Collaborators
Assiut University
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Responsible Party: Ghada Mohammed AboelFadl, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03164096    
Other Study ID Numbers: obstanesth
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents