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

NCT ID: NCT01679691

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-12-31

Brief Summary

Epidural anesthesia is a very useful tool in lower limb salvage surgery, which helps pain control intra and more importantly post-operative pain. It is a well-known effect of epidural injections to cause a sympathetic stimulation and consequently vasodilatation in the lower limb vessels.

Since epidural catheters can cause vasodilatation in lower limb vessels, they can subsequently lead to increased intra and post-operative bleeding from the surgical wound.

The study will involve all patients having a bone tumor in the lower limb and subjected to tumor resection and reconstruction by prosthesis.

The patient will be randomized according to the administration of epidural anesthesia into two arms, an arm in which epidural anesthesia was employed and another arm in which the patient was subjected only to general anesthesia and the amount of intra and postoperative bleeding will be compared in both arms.

Detailed Description

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.

Conditions

Bone Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control group

Control group in whom no epidural anesthesia will be applied

Group Type: NO_INTERVENTION

No interventions assigned to this group

Epidural Anesthesia

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

Group Type: ACTIVE_COMPARATOR

epidural anesthesia

Intervention Type: OTHER

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

Interventions

epidural anesthesia

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• lower limb bone tumor
• reconstruction by prosthesis

Exclusion Criteria

• upper limb and pelvic salvage surgery.
• other methods of reconstruction than prosthesis
• use of tourniquet intra-operative.
• post-operative anticoagulation.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Cancer Hospital Egypt 57357

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ahmed elghoneimy, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Cancer Hospital Egypt 57357

Locations

Children's Cancer Hospital Egypt-57357

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CCHE-BoneT001

Identifier Type: -

Identifier Source: org_study_id