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Median and Paramedian Anesthesia in Cesarean Section

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04617249
Recruitment Status : Not yet recruiting
First Posted : November 5, 2020
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Aljazeera Hospital

Study Description
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Brief Summary:
The number of cesarean sections worldwide has markedly been increasing since 1985.Intrathecal anesthesia is preferred by most anesthesiologists over general anesthesia

Condition or disease Intervention/treatment Phase
Anesthesia Procedure: median anesthesia Procedure: paramedian anesthesia Not Applicable

Detailed Description:
Complications with spinal anesthesia are not common which makes it difficult to detect its incidence and one of the most serious complications is nerve injury.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: anesthesia with median route versus paramedian route
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Assessment of Different Routes Median and Paramedian Anesthesia in Cesarean Section
Estimated Study Start Date : November 5, 2020
Estimated Primary Completion Date : April 25, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Giving median anesthesia Procedure: median anesthesia
giving median anesthesia
Active Comparator: Giving paramedian anesthesia Procedure: paramedian anesthesia
giving paramedian anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. the number of women who will have less pain [ Time Frame: 3 days ]
    the number of women who will have less pain post procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women undergoing CS
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-42 years
  • Scheduled for elective cesarean section
  • ASA II

Exclusion Criteria:

  • -Age <18 years or >42 years
  • ASA >II
  • Emergency cesarean section
Contacts and Locations
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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): NCT04617249


Contacts
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Contact: Mahmoud Alalfy 01002611058 mahmoudalalfy@ymail.com

Locations
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Egypt
Aljazeera( Al Gazeera) hospital
Giza, Egypt
Contact: Mahmoud Alalfy, PhD    +201002611058 ext +2    mahmoudalalfy@ymail.com   
Sponsors and Collaborators
Aljazeera Hospital
Investigators
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Study Chair: Mahmoud Alalfy Algezeera hospitaland National Research Centre ,Egypt
More Information
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Responsible Party: Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT04617249    
Other Study ID Numbers: anesthesia routes
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs