Large Volume Bupivacaine 0.5% Versus Small Volume in Elec... | NCT02937792

Studies
Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section

NCT02937792

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Oct 19, 2016Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Spinal Anesthesia

Interventions

intrathecal 15 mg bupivacaine

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 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Jan 2017Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Oct 17, 2016

First Submission Date that Met QC Criteria

Oct 18, 2016

First Posted Date

Oct 19, 2016Estimated

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 18, 2016

Last Update Posted Date

Oct 19, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hassan Mohamed Ali, lecturer in anesthesia department Cairo university, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To test the safety of high dose spinal in elective CS after prolonged sitting position.

Detailed Description

This is a prospective double-blind randomized study, designed to include cases in two groups (using epical program for sample size calculation), one study groups and one control group (parallel). Each group should have at least 30 female patients scheduled for elective caesarean section with a total of 60 cases.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CONTROL	No Intervention	one with intrathecal 12.5 mg bupivacaine
experimental	Experimental	one group with intrathecal 15 mg bupivacaine	Drug: intrathecal 15 mg bupivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intrathecal 15 mg bupivacaine	Drug	spinal anesthesia with a large dose of bupivacaine 0.5% in elective caesarean section	experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
vital signs	blood pressure, heart rate	45 minutes

Secondary Outcomes

Measure	Description	Time Frame
complications	nausea, vomiting and total spinal	45 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Full term pregnant female indicated for the elective section under spinal anesthesia with no history of medical importance

Exclusion Criteria:

Urgent cases, emergency cases, adverse medical history, anticoagulant treatment, associated pregnancy complication, failed spinal, surgical complication or refusal

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hassan Ali, lecturer	Contact	1001733687		hassan364@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University	Recruiting	Cairo	Giza Governorate	1234	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided