Chronic PainNCT02296515
Intrathecal Pump Refill Undergoing Regular Intrathecal Pump Refill
An observational study of Chronic Pain, run by Dr med. Paolo Maino Viceprimario Anestesiologia at 1 site in Switzerland.
Trial summary
Reservoir fill port identification by palpation versus ultrasound,a mono-centre prospective comparison study in patients undergoing regular intrathecal pump refill Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Intrathecal pump refill:
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Nov 2017
- Phase
- Observational
- 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
Study population: patients with an intrathecal pump for the treatment of chronic non-malignant pain or spasticity, undergoing regular refills of their intrathecal pumps at our Centro Terapia del Dolore at the Ospedale Italiano a Viganello(EOC, Switzerland).
Who may be able to join
- 18 years or older at the time of enrollment;
- The patients are treated for chronic non-malignant pain or spasticity with an intrathecal
- programmable infusion pump and undergo regular refills of their pumps in our clinic.
- Able to provide adequate given written, informed consent to participate in this study.
Who cannot join
- patient refusal to participate or provide informed consent standard exclusions; pregnancy, lactation, treatment with other investigational products.
- other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction,
- cardiovascular disease).
- infection at the puncture site -participation in another study.-
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centro del Dolore, Neurocentro, Opedale Regionale di Lugano
Lugano, Canton Ticino, 6900
About this study
Official title: Intrathecal Pump Refill: Reservoir Fill Port Identification by Palpation Versus Ultrasound,a Mono-centre Prospective Comparison Study in Patients Undergoing Regular Intrathecal Pump Refill
Reservoir fill port identification by palpation versus ultrasound,a mono-centre prospective comparison study in patients undergoing regular intrathecal pump refill
Read the detailed description
Intrathecal drug therapy with implantable intrathecal pumps is being utilized increasingly for the treatment of chronic refractory pain and spasticity. However, performing the regular refill procedures of the pumps with the commonly performed "blind" technique caries the potential risk of medication injection into the subcutaneous tissue, which can lead to an overdose.
Objective: The primary purpose of this study is to assess the accuracy of the ultrasound-guided technique for the refill procedure compared to the blind technique in subjects undergoing regular refills of their intrathecal pumps for the treatment of chronic non-malignant pain or spasticity.
Study design: Mono-center prospective efficacy and reliability study comparing two approaches to enter the fill port. Study population: The investigators will include patients with an intrathecal pump for the treatment of chronic non-malignant pain or spasticity, undergoing regular refills of their intrathecal pumps at our Centro Terapia del Dolore at the Ospedale Italiano a Viganello(EOC, Switzerland). Intervention: Two different experienced clinicians will perform one time the blind technique and two times the ultrasound-guided technique on all patients.sample size calculations can be performed. The sample size i.e. n=25 patients in NSI-TD-001 Protocol v. 1.0 Final: August 4th, 2014 Confidential Page 31 of 40 total assessed 6 six times is therefore based on practical grounds related feasibility to duration of inclusion (i.e. one year). This would imply 50 paired assessments for both fill port accuracy assessment and intra-rater reliability. The investigators believe based on clinical experience that this number would suffice to detect a difference between methods. Likewise, although no formal power calculation are available for ICC based reliability assessment, as a rule of thumb 50 paired assessments are usually considered adequate to evaluate intra-rater liability.
- Conditions
- Chronic Pain
- Being tested
- Intrathecal pump refill:
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal pump refill:Procedure or surgery
Two different experienced clinicians will perform one time the blind technique andTwo different experienced clinicians will perform one time the blind technique andtwo times the ultrasound-guided technique on all patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the number of attempts to enter the reservoir fill port.
The time to perform refill, and patient comfort associated with both procedures will be registered in order to assess user friendliness of both procedures.
Measured: 1 YearThe sample size i.e. n=25 patients in total
Secondary outcomes (5)
the number of skin puncturs
Measured: 1 YearYearThe sample size i.e. n=25 patients in total
reliability of the US guided procedure
Measured: 1 YearYearThe sample size i.e. n=25 patients
- time to perform refill (usability)
Measured: 1 YearYearThe sample size i.e. n=25 patients
patient discomfort
Measured: 1 YearYearThe sample size i.e. n=25 patients
- determine if BMI has an impact on the accuracy (the number of attempts) of the two techniques
Measured: 1 YearYearThe sample size i.e. n=25 patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr med. Paolo Maino Viceprimario Anestesiologia
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Responsible party
- Sponsor-investigator, Dr med. Paolo Maino Viceprimario Anestesiologia, Ospedale Regionale di Lugano
- Investigators
- Paolo Maino, Principal investigator, Ospedale Regionale di Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296515
- Sponsor's protocol ID
- NSI_TD_001
- Status last verified
- Dec 2017
- First submitted
- 5 Nov 2014
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Pump Refill: Reservoir Fill Port Identification by Palpation Versus Ultrasound,a Mono-centre Prospective Comparison Study in Patients Undergoing Regular Intrathecal Pump Refill
- ClinicalTrials.gov ID
- NCT02296515
- Acronym / sponsor ID
- NSI_TD_001
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dr med. Paolo Maino Viceprimario AnestesiologiaUniversity, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- Oct 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 20 Nov 2014 (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.
Reservoir fill port identification by palpation versus ultrasound,a mono-centre prospective comparison study in patients undergoing regular intrathecal pump refill
Detailed description
Intrathecal drug therapy with implantable intrathecal pumps is being utilized increasingly for the treatment of chronic refractory pain and spasticity. However, performing the regular refill procedures of the pumps with the commonly performed "blind" technique caries the potential risk of medication injection into the subcutaneous tissue, which can lead to an overdose.
Objective: The primary purpose of this study is to assess the accuracy of the ultrasound-guided technique for the refill procedure compared to the blind technique in subjects undergoing regular refills of their intrathecal pumps for the treatment of chronic non-malignant pain or spasticity.
Study design: Mono-center prospective efficacy and reliability study comparing two approaches to enter the fill port. Study population: The investigators will include patients with an intrathecal pump for the treatment of chronic non-malignant pain or spasticity, undergoing regular refills of their intrathecal pumps at our Centro Terapia del Dolore at the Ospedale Italiano a Viganello(EOC, Switzerland). Intervention: Two different experienced clinicians will perform one time the blind technique and two times the ultrasound-guided technique on all patients.sample size calculations can be performed. The sample size i.e. n=25 patients in NSI-TD-001 Protocol v. 1.0 Final: August 4th, 2014 Confidential Page 31 of 40 total assessed 6 six times is therefore based on practical grounds related feasibility to duration of inclusion (i.e. one year). This would imply 50 paired assessments for both fill port accuracy assessment and intra-rater reliability. The investigators believe based on clinical experience that this number would suffice to detect a difference between methods. Likewise, although no formal power calculation are available for ICC based reliability assessment, as a rule of thumb 50 paired assessments are usually considered adequate to evaluate intra-rater liability.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with an intrathecal pump for the treatment of chronic non-malignant pain or spasticity, undergoing regular refills of their intrathecal pumps at our Centro Terapia del Dolore at the Ospedale Italiano a Viganello(EOC, Switzerland).
Key inclusion criteria (4 listed)
- 18 years or older at the time of enrollment;
- The patients are treated for chronic non-malignant pain or spasticity with an intrathecal
- programmable infusion pump and undergo regular refills of their pumps in our clinic.
- Able to provide adequate given written, informed consent to participate in this study.
Key exclusion criteria (4 listed)
- patient refusal to participate or provide informed consent standard exclusions; pregnancy, lactation, treatment with other investigational products.
- other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction,
- cardiovascular disease).
- infection at the puncture site -participation in another study.-
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 |
|---|---|---|
| Intrathecal pump refill:Two different experienced clinicians will perform one time the blind technique andTwo different experienced clinicians will perform one time the blind technique andtwo times the ultrasound-guided technique on all patients. | Procedure or surgery | – |
Primary outcome
The primary endpoint will be the number of attempts to enter the reservoir fill port.
Time frame: 1 YearThe sample size i.e. n=25 patients in total
The time to perform refill, and patient comfort associated with both procedures will be registered in order to assess user friendliness of both procedures.
5 secondary outcomes
the number of skin puncturs
Time frame: 1 YearYearThe sample size i.e. n=25 patients in total
reliability of the US guided procedure
Time frame: 1 YearYearThe sample size i.e. n=25 patients
- time to perform refill (usability)
Time frame: 1 YearYearThe sample size i.e. n=25 patients
patient discomfort
Time frame: 1 YearYearThe sample size i.e. n=25 patients
- determine if BMI has an impact on the accuracy (the number of attempts) of the two techniques
Time frame: 1 YearYearThe sample size i.e. n=25 patients
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 3 Jan 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.
Paolo Maino principal investigator
Ospedale Regionale di Lugano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Dr med. Paolo Maino Viceprimario Anestesiologia at 1 site in Switzerland.
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 4 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 3 Jan 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 Switzerland. 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 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?
The primary endpoint will be the number of attempts to enter the reservoir fill port. (time frame: 1 YearThe sample size i.e. n=25 patients in total). 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 3 Jan 2018.