Postoperative PainHLOCSTIM2NCT01726192
Comparison of Two Techniques for Placement of Perineural Femoral Catheters.
A study testing Placement of a femoral catheter with the hydrolocalization technique and Placement of a femoral neurostimulating catheter in people with Postoperative Pain and Anterior Cruciate Ligament Reconstruction, 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 femoral perineural catheters in comparison with 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
- Postoperative Pain, Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Placement of a femoral catheter with the hydrolocalization technique and Placement of a femoral neurostimulating catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2012to Jan 2013
- 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 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 Ultrasound Hydrolocalization Technique Versus Neurostimulation for Placement of Continuous Femoral Catheters.
The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of femoral perineural catheters in comparison with stimulating catheters. A non inferiority trial.
Read the detailed description
The investigators will randomize patients that will undergo anterior cruciate ligament reconstruction.
Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group HLOC) or a neurostimulating catheter (group NS).
- Being tested
- Placement of a femoral catheter with the hydrolocalization technique, Placement of a femoral neurostimulating catheter
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of a femoral catheter with the hydrolocalization techniqueProcedure or surgery
Also called Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
Placement of a femoral neurostimulating catheterProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HLOC | Active comparator | Placement of a femoral catheter with the hydrolocalization technique Receives: Procedure: Placement of a femoral catheter with the hydrolocalization technique |
| NS | Active comparator | Placement of a femoral neurostimulating catheter Receives: Procedure: Placement of a femoral neurostimulating catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
local anesthetic consumption
Measured: 36 hours postoperatively
Secondary outcomes (1)
Pain scores with a VAS scale
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 posted14 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionJan 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 Postoperative 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 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 HospitalMario Dauri, MD, Principal investigator, Policlinico Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726192
- Sponsor's protocol ID
- HLOCSTIM2
- Acronym
- HLOCSTIM2
- Status last verified
- Nov 2012
- First submitted
- 9 Nov 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- 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 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Hydrolocalization Technique Versus Neurostimulation for Placement of Continuous Femoral Catheters.
- ClinicalTrials.gov ID
- NCT01726192
- Acronym / sponsor ID
- HLOCSTIM2 / HLOCSTIM2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (estimated)
- First posted
- 14 Nov 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 femoral perineural catheters in comparison with stimulating catheters. A non inferiority trial.
Detailed description
The investigators will randomize patients that will undergo anterior cruciate ligament reconstruction.
Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group HLOC) or a neurostimulating catheter (group NS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLOC | Active comparator | Procedure: Placement of a femoral catheter with the hydrolocalization techniquePlacement of a femoral catheter with the hydrolocalization technique |
| NS | Active comparator | Procedure: Placement of a femoral neurostimulating catheterPlacement of a femoral neurostimulating catheter |
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 a femoral catheter with the hydrolocalization techniqueAlso: Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6% | Procedure or surgery | HLOC |
| Placement of a femoral neurostimulating catheter | Procedure or surgery | NS |
Primary outcome
local anesthetic consumption
Time frame: 36 hours postoperatively
1 secondary outcome
Pain scores with a VAS scale
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 14 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
Mario Dauri, MD principal investigator
Policlinico Tor Vergata
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of a femoral catheter with the hydrolocalization technique and Placement of a femoral neurostimulating catheter in people with Postoperative Pain and Anterior Cruciate Ligament Reconstruction, 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 14 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.
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?
local anesthetic consumption (time frame: 36 hours postoperatively). 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 NCT01726192, 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 14 Nov 2012.