Tab Block and Patient Controlled Analgesia in CS | NCT04405336

Studies
Tab Block and Patient Controlled Analgesia in CS

NCT04405336

Sponsor

Aljazeera Hospital

Status

Completed

Last Update Posted

May 25, 2021Actual

Enrollment

140Actual

Phase

Not Applicable

Conditions

Analgesia

Interventions

tab block
PCA
women who will not receive tab block or PCA

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

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2020Actual

Primary Completion Date

Mar 15, 2021Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

May 23, 2020

First Submission Date that Met QC Criteria

May 23, 2020

First Posted Date

May 28, 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

May 21, 2021

Last Update Posted Date

May 25, 2021Actual

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

cesarean section rate become increasing nowadays

Detailed Description

indication of cesarean section are different from case to case and the use of pain controlling agents is very important to relieve post operative pain

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

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
giving tab block	Active Comparator	giving patients tab block	Drug: tab block Drug: women who will not receive tab block or PCA
giving PCA	Active Comparator	Giving PCA to patients	Drug: PCA Drug: women who will not receive tab block or PCA
Patients who will not receive PCA or tab block	No Intervention	No tab block or PCA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tab block	Drug	injection of tab block to women who are doing cs	giving tab block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of women who will feel less pain post CS	the degree of pain that will be felt post CS	2 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women coming for an elective CS

Exclusion Criteria:

women who has a n emergency CS or complicated normal deivery needs urgent CS

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

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

Not provided

Overall Officials

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

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003766	Dental Occlusion
D010323	Passive Cutaneous Anaphylaxis

Ancestor Terms

ID	Term
D003813	Dentistry
D009063	Dental Physiological Phenomena
D055688	Digestive System and Oral Physiological Phenomena
D012882	Skin Tests

Browse Leaves

Not provided

Browse Branches

Not provided