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

Not Applicable

Withdrawn

• Conditions: Bone Tumor
• Interventions: Other: epidural anesthesia

• Registration Number: NCT01679691
• Lead Sponsor: Children's Cancer Hospital Egypt 57357

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-08-12
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-06
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-15
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Anesthesia	epidural anesthesia	the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative

Primary Outcome Measures

Name	Time	Method
Measure the blood loss intra- and post-operative in both the contro and study groups	start of surgery until removal of sucction drain	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.

Secondary Outcome Measures

Name	Time	Method
prolongation of hospital stay	the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days	the number of days calculated from date of surgery until discharge from hospital expected average from 5 to 7 days

Trial Locations

Locations (1)

Children's Cancer Hospital Egypt-57357; 🇪🇬 Cairo, Egypt