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

Primary Purpose

Bone Tumor

Status
Withdrawn
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
epidural anesthesia
Sponsored by
Children's Cancer Hospital Egypt 57357
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bone Tumor

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Children's Cancer Hospital Egypt-57357

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Epidural Anesthesia

Arm Description

Control group in whom no epidural anesthesia will be applied

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2012
Last Updated
April 15, 2018
Sponsor
Children's Cancer Hospital Egypt 57357
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1. Study Identification

Unique Protocol Identification Number
NCT01679691
Brief Title
The Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Post Lower Limb Salvage Surgery
Official Title
The Effect of Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Following Lower Limb Salvage Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Till IRB renewal
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Cancer Hospital Egypt 57357

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Tumor

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group in whom no epidural anesthesia will be applied
Arm Title
Epidural Anesthesia
Arm Type
Active Comparator
Arm Description
the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative
Intervention Type
Other
Intervention Name(s)
epidural anesthesia
Intervention Description
the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative
Primary Outcome Measure Information:
Title
Measure the blood loss intra- and post-operative in both the contro and study groups
Description
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.
Time Frame
start of surgery until removal of sucction drain
Secondary Outcome Measure Information:
Title
prolongation of hospital stay
Description
the number of days calculated from date of surgery until discharge from hospital expected average from 5 to 7 days
Time Frame
the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed elghoneimy, MD
Organizational Affiliation
Children's Cancer Hospital Egypt 57357
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Cancer Hospital Egypt-57357
City
Cairo
ZIP/Postal Code
11441
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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