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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bone Tumor

Intervention / Treatment
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* Other: epidural anesthesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group in whom no epidural anesthesia will be applied | |
| Active Comparator: Epidural Anesthesia<br>the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative | Other: epidural anesthesia<br>* the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the blood loss intra- and post-operative in both the contro and study groups | The amount of blood loss will be assessed using: Intra-operative: measurement of dressing before and after being soaked. Post-operative: amount of blood drainage and duration of use of the suction drain. | start of surgery until removal of sucction drain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prolongation of hospital stay | the number of days calculated from date of surgery until discharge from hospital expected average from 5 to 7 days | the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days |