Intrathecal Pump Refill Undergoing Regular Intrathecal Pump Refill

Study Overview
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Brief Summary
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Reservoir fill port identification by palpation versus ultrasound,a mono-centre prospective comparison study in patients undergoing regular intrathecal pump refill

Detailed Description
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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.

Official Title
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Intrathecal Pump Refill: Reservoir Fill Port Identification by Palpation Versus Ultrasound,a Mono-centre Prospective Comparison Study in Patients Undergoing Regular Intrathecal Pump Refill

Conditions
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Chronic Pain

Intervention / Treatment
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* Procedure: Intrathecal pump refill:


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.-

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 YearThe sample size i.e. n=25 patients in total | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of skin puncturs |  | 1 YearYearThe sample size i.e. n=25 patients in total | 
| reliability of the US guided procedure |  | 1 YearYearThe sample size i.e. n=25 patients | 
| - time to perform refill (usability) |  | 1 YearYearThe sample size i.e. n=25 patients | 
| patient discomfort |  | 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 |  | 1 YearYearThe sample size i.e. n=25 patients |