NCT04376086

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

April 10, 2020

Last Update Submit

May 4, 2021

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (2)

  • Analgesic requirements

    Analgesic requirments

    first 24 hours

  • Haemodynamics

    blood pressure

    periooperative time

Secondary Outcomes (1)

  • VAS score

    24 hours

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

Patients will receive general anesthesia

Procedure: general anesthesia

Epidural anesthesia

EXPERIMENTAL

Patients will receive epidural anesthesia

Procedure: Epidural anesthesia

Interventions

Epidural anesthesiaPROCEDURE

Segmental epidural analgesia

Epidural anesthesia
general anesthesiaPROCEDURE

general anesthesia

General anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for surgical feeding jejunostomy more than 18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

MeSH Terms

Interventions

Anesthesia, EpiduralAnesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Walaa Y Elsabeeny, MD

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and pain management

Study Record Dates

First Submitted

April 10, 2020

First Posted

May 6, 2020

Study Start

June 10, 2019

Primary Completion

April 25, 2021

Study Completion

April 26, 2021

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations

EG(1)