Intrathecal Pump Refill Undergoing Regular Intrathecal Pump Refill

NCT02296515 | Completed

• 1 other identifier: NSI_TD_001
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Interventions

Intrathecal pump refill: PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction,
• cardiovascular disease).
• infection at the puncture site -participation in another study.-

Sponsors & Collaborators

• Dr med. Paolo Maino Viceprimario Anestesiologia: lead
• VU University of Amsterdam: collaborator

Study Sites (1)

Centro del Dolore, Neurocentro, Opedale Regionale di Lugano

Lugano, Canton Ticino, 6900, Switzerland

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Maino

  Ospedale Regionale di Lugano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med deputy Head of the Anesthisiology

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 20, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

CH (1)