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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bone Tumor
• Intervention / Treatment: Other: epidural anesthesia

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11441
    • Children's cancer Hospital Egypt-57357

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Cancer Hospital Egypt 57357
• Investigators: Principal Investigator: ahmed elghoneimy, MD, Children's Cancer Hospital Egypt 57357

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 12, 2012
• First Submitted That Met QC Criteria: September 3, 2012
• First Posted (Estimate): September 6, 2012

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 15, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Bone Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CCHE-BoneT001