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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01679691
Enrollment
0
Registered
2012-09-06
Start date
2011-09-30
Completion date
2016-12-31
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Tumor

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.

Interventions

OTHERepidural anesthesia

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

Sponsors

Children's Cancer Hospital Egypt 57357
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Measure the blood loss intra- and post-operative in both the contro and study groupsstart of surgery until removal of sucction drainThe 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

MeasureTime frameDescription
prolongation of hospital staythe number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 daysthe number of days calculated from date of surgery until discharge from hospital expected average from 5 to 7 days

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026