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

Bone Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01679691
• Other study ID #: CCHE-BoneT001
• Status: Withdrawn
• Phase: N/A
• First received: August 12, 2012
• Last updated: April 15, 2018
• Start date: September 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2018
• Source: Children's Cancer Hospital Egypt 57357
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Tumor

Intervention

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

Locations

Country	Name	City	State
Egypt	Children's Cancer Hospital Egypt-57357	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer Hospital Egypt 57357

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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