Intrathecal Pump Refill Undergoing Regular Intrathecal Pump Refill

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296515
• Other study ID #: NSI_TD_001
• Status: Completed
• Phase: N/A
• First received: November 5, 2014
• Last updated: December 30, 2017
• Start date: October 2014
• Est. completion date: November 2017

Study information

• Verified date: December 2017
• Source: Ospedale Regionale di Lugano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.-

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Centro del Dolore, Neurocentro, Opedale Regionale di Lugano	Lugano	Ticino

Sponsors (2)

Lead Sponsor	Collaborator
Dr med. Paolo Maino Viceprimario Anestesiologia	VU University of Amsterdam

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the number of skin puncturs		1 YearYearThe sample size i.e. n=25 patients in total
Secondary	reliability of the US guided procedure		1 YearYearThe sample size i.e. n=25 patients
Secondary	- time to perform refill (usability)		1 YearYearThe sample size i.e. n=25 patients
Secondary	patient discomfort		1 YearYearThe sample size i.e. n=25 patients
Secondary	- 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