Phantom Limb PainPhase 4NCT00528463
Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain
A Phase 4 study testing sciatic nerve block in people with Phantom Limb Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Phantom limb pain is a complication of amputation. Although pre-empitve epidural analgesia was once thought to prevent such a com plication, recent studies did not demonstrate this. Peripheral blocks are more powerful then epidurals, and can even influence somatotropic representation in the brain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- sciatic nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2005to Sep 2007
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient scheduled for lower limb amputation
Who cannot join
- Inability to consent
- Contraindication to peripheral nerve block
- Inability to perform the block
- Inadequate time frame (less than 24 hours prior to surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: a Prospective Case Series of Pre-emptive Pre-amputation Sciatic Nerve Block to Prevent Lower Limb Phantom Pain
Phantom limb pain is a complication of amputation. Although pre-empitve epidural analgesia was once thought to prevent such a com plication, recent studies did not demonstrate this. Peripheral blocks are more powerful then epidurals, and can even influence somatotropic representation in the brain. This a prospective case series in which the investigators hope to show a decrease, against historical control, of the incidence of post-operative amputation lower limb phantom pain. The investigators established the block at least 24 hours pre-operative and continue it for at least 2 days. Patient are followed daily for the 1st 3 days and then up to 3 month for the incidence of phantom limb pain. The investigators hope to recruit 30 patients.
- Conditions
- Phantom Limb Pain
- Being tested
- sciatic nerve block
- Keywords
- Pre-emptive analgesia, Peripheral nerve block (sciatic), phantom lomb pain
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sciatic nerve blockProcedure or surgery
Sciatic nerve block, Labatt approach, with a stimuplex needle and catheter. Once localized, a bolus of 20 mL ropivacaine 1,0% is given through the catheter and is followed by a perfusion of ropivacaine 0,2% 6-10 mL/hre for at least 24 hours pre-op and 48 hours post-op
| Study group | Role | What they receive |
|---|---|---|
| sciatic block | Experimental | One arm, all patient studied received a block Receives: Procedure: sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of lower limb phantom pain
Measured: 3 month post amputation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startJan 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Investigators
- ETIENNE DE MEDICIS, MD, MSC, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528463
- Sponsor's protocol ID
- edm1
- Status last verified
- Sep 2007
- First submitted
- 10 Sep 2007
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Prospective Case Series of Pre-emptive Pre-amputation Sciatic Nerve Block to Prevent Lower Limb Phantom Pain
- ClinicalTrials.gov ID
- NCT00528463
- Acronym / sponsor ID
- edm1
- Conditions
- Phantom Limb Pain
- Keywords
- Pre-emptive analgesia, Peripheral nerve block (sciatic), phantom lomb pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Sep 2007 (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.
Phantom limb pain is a complication of amputation. Although pre-empitve epidural analgesia was once thought to prevent such a com plication, recent studies did not demonstrate this. Peripheral blocks are more powerful then epidurals, and can even influence somatotropic representation in the brain. This a prospective case series in which the investigators hope to show a decrease, against historical control, of the incidence of post-operative amputation lower limb phantom pain. The investigators established the block at least 24 hours pre-operative and continue it for at least 2 days. Patient are followed daily for the 1st 3 days and then up to 3 month for the incidence of phantom limb pain. The investigators hope to recruit 30 patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sciatic block | Experimental | Procedure: sciatic nerve blockOne arm, all patient studied received a block |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient scheduled for lower limb amputation
Key exclusion criteria (4 listed)
- Inability to consent
- Contraindication to peripheral nerve block
- Inability to perform the block
- Inadequate time frame (less than 24 hours prior to surgery)
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 |
|---|---|---|
| sciatic nerve blockSciatic nerve block, Labatt approach, with a stimuplex needle and catheter. Once localized, a bolus of 20 mL ropivacaine 1,0% is given through the catheter and is followed by a perfusion of ropivacaine 0,2% 6-10 mL/hre for at least 24 hours pre-op and 48 hours post-op | Procedure or surgery | sciatic block |
Primary outcome
incidence of lower limb phantom pain
Time frame: 3 month post amputation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
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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.
ETIENNE DE MEDICIS, MD, MSC principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sciatic nerve block in people with Phantom Limb Pain, run by Université de Sherbrooke at 1 site in Canada.
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 1 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: finished, as of the sponsor's last update on 2 Feb 2010. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of lower limb phantom pain (time frame: 3 month post amputation). 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 2 Feb 2010.