Segmental Epidural Block for Feeding Jeujunostomy in Canc... | NCT04376086

Studies
Segmental Epidural Block for Feeding Jeujunostomy in Cancer Patients

NCT04376086

Sponsor

National Cancer Institute, Egypt

Status

Completed

Last Update Posted

May 7, 2021Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Anesthesia

Interventions

Epidural anesthesia
general 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

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

Jun 10, 2019Actual

Primary Completion Date

Apr 25, 2021Actual

Completion Date

Apr 26, 2021Actual

First Submitted Date

Apr 10, 2020

First Submission Date that Met QC Criteria

May 4, 2020

First Posted Date

May 6, 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 4, 2021

Last Update Posted Date

May 7, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Walaa Youssef Elsabeeny, Lecturer of anesthesia and pain management, National Cancer Institute, EgyptPrincipal Investigator

Lead Sponsor

National Cancer Institute, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This study aim is to compare the efficiency and safety of segmental epidural block versus general anesthesia in cancer patients undergoing surgical feeding jejunostomy

Detailed Description

Comparing general anesthesia versus segmental epidural anesthesia in feeding jejunostomy

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

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General anesthesia	Active Comparator	Patients will receive general anesthesia	Procedure: general anesthesia
Epidural anesthesia	Experimental	Patients will receive epidural anesthesia	Procedure: Epidural anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epidural anesthesia	Procedure	Segmental epidural analgesia	Epidural anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analgesic requirements	Analgesic requirments	first 24 hours
Haemodynamics	blood pressure	periooperative time

Secondary Outcomes

Measure	Description	Time Frame
VAS score	visual analouge scale 0 minimum to 10 maximum score	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients scheduled for surgical feeding jejunostomy more than 18 years old

Exclusion Criteria:

patien refusal Coagulation defect Abnormal kidney or liver functions Local infection at site of block Bone metastases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walaa Y Elsabeeny, MD	Lecturer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute		Cairo		11796	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D000767	Anesthesia, Epidural
D000768	Anesthesia, General

Ancestor Terms

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided