Regional Anesthesia | NCT04933500

Studies
Regional Anesthesia

NCT04933500

Sponsor

Reham Ali Abdelhaleem Abdelrahman

Status

Completed

Last Update Posted

Dec 15, 2022Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Anesthetic Regional Techniques for Vaginal Surgeries

Interventions

Whitacre spinal needle

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

Dec 2022

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

Jul 1, 2021Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Dec 1, 2022Actual

First Submitted Date

Jun 16, 2021

First Submission Date that Met QC Criteria

Jun 18, 2021

First Posted Date

Jun 21, 2021Actual

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

Dec 13, 2022

Last Update Posted Date

Dec 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Reham Ali Abdelhaleem Abdelrahman, Anesthesia lecturer M.D., Cairo UniversitySponsor-Investigator

Lead Sponsor

Reham Ali Abdelhaleem AbdelrahmanOTHER

Collaborators

Not provided

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

Both techniques are efficacious for sacral anesthesia during vaginal surgeries. Dural puncture epidural technique allows partial confirmation of epidural catheter placement.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional epidural		epidural needle: Tuhoy needle 1.3mm (18 G) with 20G multi-orifice epidural catheter
Dural puncture epidural		epidural needle;Tuhoy needle 1.3mm (18G)with 20G multi-orifice epidural catheter and 25G Whitacre spinal needle	Device: Whitacre spinal needle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whitacre spinal needle	Device	25G Whitacre spinal needle	Dural puncture epidural

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Onset of bilateral sacral sensory loss	sacral sensory loss is observed by needle brick	4months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-II

--Age(25-55)years
Height(150-170cm)

Exclusion Criteria:

patient refusal
severe mitral or aortic stenosis

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

adult female Egyptian patients

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Abdelrahman		Cairo		11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided