Bone TumorNCT01679691
The Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Post Lower Limb Salvage Surgery
A study testing epidural anesthesia in people with Bone Tumor, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Bone Tumor
- What is being tested?
- epidural anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- lower limb bone tumor
- reconstruction by prosthesis
Who cannot join
- upper limb and pelvic salvage surgery.
- other methods of reconstruction than prosthesis
- use of tourniquet intra-operative.
- post-operative anticoagulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Bone Tumor
- Being tested
- epidural anesthesia
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural anesthesiaOther
the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 discharge from hospital expected average from 5 to 7 days
Measured: the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Till IRB renewal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ahmed elghoneimy, MD, Principal investigator, Children's Cancer Hospital Egypt 57357
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679691
- Sponsor's protocol ID
- CCHE-BoneT001
- Status last verified
- Apr 2018
- First submitted
- 12 Aug 2012
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Following Lower Limb Salvage Surgery
- ClinicalTrials.gov ID
- NCT01679691
- Acronym / sponsor ID
- CCHE-BoneT001
- Conditions
- Bone Tumor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Till IRB renewal
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group in whom no epidural anesthesia will be applied |
| Epidural Anesthesia | Active comparator | Other: epidural anesthesiathe group in whom all patients will be subjected to epidural anesthesia intra- and post-operative |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- lower limb bone tumor
- reconstruction by prosthesis
Key exclusion criteria (4 listed)
- upper limb and pelvic salvage surgery.
- other methods of reconstruction than prosthesis
- use of tourniquet intra-operative.
- post-operative anticoagulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural anesthesiathe group in whom all patients will be subjected to epidural anesthesia intra- and post-operative | Other | Epidural Anesthesia |
Primary outcome
Measure the blood loss intra- and post-operative in both the contro and study groups
Time frame: start of surgery until removal of sucction drain
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.
1 secondary outcome
prolongation of hospital stay
Time frame: the number of days calculated from date of surgery until dischare from hospital expected average from 5 to 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed elghoneimy, MD principal investigator
Children's Cancer Hospital Egypt 57357
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural anesthesia in people with Bone Tumor, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the blood loss intra- and post-operative in both the contro and study groups (time frame: start of surgery until removal of sucction drain). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.