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

This study has suspended participant recruitment.
(Till IRB renewal)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01679691
First Posted: September 6, 2012
Last Update Posted: January 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Cancer Hospital Egypt 57357
  Purpose

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.


Condition Intervention
Bone Tumor Other: epidural anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effect of Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Following Lower Limb Salvage Surgery

Resource links provided by NLM:


Further study details as provided by Children's Cancer Hospital Egypt 57357:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • prolongation of hospital stay [ Time Frame: the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days ]

Estimated Enrollment: 45
Study Start Date: September 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Control group in whom no epidural anesthesia will be applied
Active Comparator: Epidural Anesthesia
the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative
Other: epidural anesthesia
the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679691


Locations
Egypt
Children's Cancer Hospital Egypt-57357
Cairo, Egypt, 11441
Sponsors and Collaborators
Children's Cancer Hospital Egypt 57357
Investigators
Principal Investigator: ahmed elghoneimy, MD Children's Cancer Hospital Egypt 57357
  More Information

Responsible Party: Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier: NCT01679691     History of Changes
Other Study ID Numbers: CCHE-BoneT001
First Submitted: August 12, 2012
First Posted: September 6, 2012
Last Update Posted: January 12, 2016
Last Verified: September 2012

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs