Foot SurgeryPhase 4NCT01546077
Placement of Perineural Catheters in the Popliteal Region
A Phase 4 study testing Placement of perineural catheters with Hydrolocalization technique using in people with Foot Surgery, run by Attikon Hospital at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of popliteal perineural catheters in comparison with the stimulating catheters. A non inferiority trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Surgery
- What is being tested?
- Placement of perineural catheters with Hydrolocalization technique using
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2012to Mar 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- BMI less than 30
Who cannot join
- known allergies to local anesthetics or other drugs used
- patient refusal
- any local or systemic contraindication to the use of popliteal block
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Greece1 site, 1 recruiting
- Recruiting
Attikon Hospital
Athens
Tatiana F Sidiropoulou, MD, PhD
Theodosios Saranteas, MD, PhD
Italy1 site, 1 recruiting
- Recruiting
Policlinico Tor Vergata
Rome
Mario Dauri, MD, mario.dauri@ptvonline.it
Mario Dauri, MD
About this study
Official title: Comparison of Techniques for Placement of Perineural Catheters in the Popliteal Region
The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of popliteal perineural catheters in comparison with the stimulating catheters. A non inferiority trial.
- Conditions
- Foot Surgery
- Being tested
- Placement of perineural catheters with Hydrolocalization technique using
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of perineural catheters with Hydrolocalization technique usingProcedure or surgery
Placement of perineural catheters in the popliteal region comparing two techniques. while the drugs used are the same (ropivacaine 0.6% for initial bolus and 0.2% for continuous technique) we will compare dosage required in each group
| Study group | Role | What they receive |
|---|---|---|
| Hydrolocalization technique group | Active comparator | Technique of placement of popliteal perineural catheter using the hydrolocalization technique with ultrasound Receives: Procedure: Placement of perineural catheters with Hydrolocalization technique using |
| Stimulating Catheter technique group | Active comparator | A technique for placement of popliteal catheter with the aid of a neurostimulator Receives: Procedure: Placement of perineural catheters with Hydrolocalization technique using |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of local anesthetics
Measured: 36 hours PO
Secondary outcomes (1)
pain scores
Measured: 36 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foot SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidiropoulou Tatiana, Attikon Hospital
- Investigators
- Tatiana F Sidiropoulou, MD, PhD, Principal investigator, Attikon HospitalTheodosios Saranteas, MD, PhD, Principal investigator, Attikon HospitalGeorgia G Kostopanagiotou, MD, PhD, Study chair, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546077
- Sponsor's protocol ID
- HLOCSTIM1
- Status last verified
- Nov 2012
- First submitted
- 3 Feb 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
Publications
Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. No abstract available.
PubMed 22088876
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Techniques for Placement of Perineural Catheters in the Popliteal Region
- ClinicalTrials.gov ID
- NCT01546077
- Acronym / sponsor ID
- HLOCSTIM1
- Conditions
- Foot Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (estimated)
- First posted
- 7 Mar 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.
The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of popliteal perineural catheters in comparison with the stimulating catheters. A non inferiority trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrolocalization technique group | Active comparator | Procedure: Placement of perineural catheters with Hydrolocalization technique usingTechnique of placement of popliteal perineural catheter using the hydrolocalization technique with ultrasound |
| Stimulating Catheter technique group | Active comparator | Procedure: Placement of perineural catheters with Hydrolocalization technique usingA technique for placement of popliteal catheter with the aid of a neurostimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults
- BMI less than 30
Key exclusion criteria (3 listed)
- known allergies to local anesthetics or other drugs used
- patient refusal
- any local or systemic contraindication to the use of popliteal block
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 |
|---|---|---|
| Placement of perineural catheters with Hydrolocalization technique usingPlacement of perineural catheters in the popliteal region comparing two techniques. while the drugs used are the same (ropivacaine 0.6% for initial bolus and 0.2% for continuous technique) we will compare dosage required in each group | Procedure or surgery | Hydrolocalization technique group, Stimulating Catheter technique group |
Primary outcome
consumption of local anesthetics
Time frame: 36 hours PO
1 secondary outcome
pain scores
Time frame: 36 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
- Background: PubMed 22088876Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. No abstract available.
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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.
Tatiana F Sidiropoulou, MD, PhD principal investigator
Attikon Hospital
Theodosios Saranteas, MD, PhD principal investigator
Attikon Hospital
Georgia G Kostopanagiotou, MD, PhD study chair
Attikon Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Placement of perineural catheters with Hydrolocalization technique using in people with Foot Surgery, run by Attikon Hospital at 2 sites in 2 countries.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece, Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana F Sidiropoulou, MD, PhD (00302105832371, tatianasid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption of local anesthetics (time frame: 36 hours PO). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01546077, which also lists 1 linked publication.
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 12 Nov 2012.