Segmental Epidural Block for Feeding Jeujunostomy in Cancer Patients

May 4, 2021 updated by: Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

Segmental Epidural Block for Feeding Jejunostomy in Cancer Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparing general anesthesia versus segmental epidural anesthesia in feeding jejunostomy

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11796
        • National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: General anesthesia
Patients will receive general anesthesia
Procedure: general anesthesia
general anesthesia
EXPERIMENTAL: Epidural anesthesia
Patients will receive epidural anesthesia
Procedure: Epidural anesthesia
Segmental epidural analgesia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 10, 2019

Primary Completion (ACTUAL)

April 25, 2021

Study Completion (ACTUAL)

April 26, 2021

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (ACTUAL)

May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP1904-50103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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