Clinical trial NCT02296515: Intrathecal Pump Refill Undergoing Regular Intrathecal Pump Refill
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Ospedale Regionale di Lugano
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2014-11-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief summary: 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.

Eligibility criteria: 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.-

Primary outcomes:
measure: The primary endpoint will be the number of attempts to enter the reservoir fill port.
timeFrame: 1 YearThe sample size i.e. n=25 patients in total
Secondary outcomes:
measure: the number of skin puncturs
timeFrame: 1 YearYearThe sample size i.e. n=25 patients in total
measure: reliability of the US guided procedure
timeFrame: 1 YearYearThe sample size i.e. n=25 patients
measure: - time to perform refill (usability)
timeFrame: 1 YearYearThe sample size i.e. n=25 patients
measure: patient discomfort
timeFrame: 1 YearYearThe sample size i.e. n=25 patients
measure: - determine if BMI has an impact on the accuracy (the number of attempts) of the two techniques
timeFrame: 1 YearYearThe sample size i.e. n=25 patients
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Centro del Dolore, Neurocentro, Opedale Regionale di Lugano
state: Ticino
Study officials:
affiliation: Ospedale Regionale di Lugano
name: Paolo Maino
role: PRINCIPAL_INVESTIGATOR
References: