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

Children's Cancer Hospital Egypt 57357

Status: Withdrawn

Conditions: Bone Tumor

Treatments: Other: epidural anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01679691

CCHE-BoneT001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control group

No Intervention group

Description:

Control group in whom no epidural anesthesia will be applied

Epidural Anesthesia

Active Comparator group

Description:

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

Treatment:

Other: epidural anesthesia