- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04376086
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
-
-
-
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
|
general anesthesia
|
EXPERIMENTAL: Epidural anesthesia
Patients will receive 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
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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