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

NCT01679691 | Withdrawn DMC

• 1 other identifier: CCHE-BoneT001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Arms (2)

Control group

NO INTERVENTION

Control group in whom no epidural anesthesia will be applied

Epidural Anesthesia

ACTIVE COMPARATOR

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

Other: epidural anesthesia

Interventions

epidural anesthesia OTHER

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

Epidural Anesthesia

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• lower limb bone tumor
• reconstruction by prosthesis

You may not qualify if:

• upper limb and pelvic salvage surgery.
• other methods of reconstruction than prosthesis
• use of tourniquet intra-operative.
• post-operative anticoagulation.

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead

Study Sites (1)

Children's Cancer Hospital Egypt-57357

Cairo, 11441, Egypt

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• ahmed elghoneimy, MD

  Children's Cancer Hospital Egypt 57357

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2012
• First Posted: September 6, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

EG (1)