Median and Paramedian Anesthesia in Cesarean Section | NCT04617249

Studies
Median and Paramedian Anesthesia in Cesarean Section

NCT04617249

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Nov 5, 2020Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Anesthesia

Interventions

median anesthesia
paramedian anesthesia

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2020Estimated

Primary Completion Date

Apr 25, 2021Estimated

Completion Date

May 15, 2021Estimated

First Submitted Date

Oct 31, 2020

First Submission Date that Met QC Criteria

Oct 31, 2020

First Posted Date

Nov 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2020

Last Update Posted Date

Nov 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Giving median anesthesia	Active Comparator		Procedure: median anesthesia
Giving paramedian anesthesia	Active Comparator		Procedure: paramedian anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
median anesthesia	Procedure	giving median anesthesia	Giving median anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of women who will have less pain	the number of women who will have less pain post procedure	3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women undergoing CS

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Alalfy	Contact	01002611058		mahmoudalalfy@ymail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy	Algezeera hospitaland National Research Centre ,Egypt	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aljazeera( Al Gazeera) hospital		Giza			Egypt