Suspended

The Effect of Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Following Lower Limb Salvage Surgery

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What is being tested

epidural anesthesia

Other
Who is being recruted

Bone Diseases+2

+ Musculoskeletal Diseases

+ Neoplasms

From 5 to 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: September 2011
See protocol details

Summary

Principal SponsorChildren's Cancer Hospital Egypt 57357
Last updated: April 17, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2011

Actual date on which the first participant was enrolled.

Assessment of intra-operative bleeding will be based upon weighing and counting of the blood soaked dressing and the amount of blood transfusion used. Assessment of post-operative bleeding will be based upon the amount of blood collected from the suction drain and amount of blood transfusion. All patient subjected to anticoagulant post-operative or another type of surgery other than implantation of prosthesis will be excluded from the study.

NCT01679691
Principal SponsorChildren's Cancer Hospital Egypt 57357
Last updated: April 17, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

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

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesMusculoskeletal DiseasesNeoplasmsNeoplasms by SiteBone Neoplasms

Criteria

2 inclusion criteria required to participate
lower limb bone tumor
reconstruction by prosthesis
4 exclusion criteria prevent from participating
other methods of reconstruction than prosthesis
post-operative anticoagulation
upper limb and pelvic salvage surgery
use of tourniquet intra-operative

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
Control group in whom no epidural anesthesia will be applied

Group II

Active Comparator
the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Children's Cancer Hospital Egypt-57357

Cairo, EgyptOpen Children's Cancer Hospital Egypt-57357 in Google Maps
SuspendedOne Study Center