Intrathecal Pump Refill Undergoing Regular Intrathecal Pump Refill

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Switzerland
  • Ticino
    • Lugano, Ticino, Switzerland, 6900
      • Centro del Dolore, Neurocentro, Opedale Regionale di Lugano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Dr med. Paolo Maino Viceprimario Anestesiologia
• Collaborators: VU University of Amsterdam
• Investigators: Principal Investigator: Paolo Maino, Ospedale Regionale di Lugano

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 30, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: NSI_TD_001