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Clinical Trials/NCT01679691
NCT01679691
Withdrawn
Not Applicable

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

Children's Cancer Hospital Egypt 573571 site in 1 countrySeptember 2011
ConditionsBone Tumor

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Tumor
Sponsor
Children's Cancer Hospital Egypt 57357
Locations
1
Primary Endpoint
Measure the blood loss intra- and post-operative in both the contro and study groups
Status
Withdrawn
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Children's Cancer Hospital Egypt 57357
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Measure the blood loss intra- and post-operative in both the contro and study groups

Time Frame: 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 Outcomes

  • prolongation of hospital stay(the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days)

Study Sites (1)

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