The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study

Completed

• Conditions: Chronic Pain Syndrome
• Interventions: Drug: opiate with bolus

• Registration Number: NCT02197741
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

Brief Summary

An additional, intermittent bolus application in patients with intrathecal opiate administration for chronic pain syndrome may have a positive effect on the effectiveness of the treatment. Thus, the effect of an additional, intermittent bolus application in patients with intrathecal opiate administration was therefore investigated.

Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each patient was submitted to two treatment periods in randomly chosen order (cross-over design): 1. standard treatment (continuous opiate administration) and 2. continuous opiate administration with intermittent opiate bolus application. Both treatment periods lasted 14 days. Patients were asked to record pain intensity, side effects and satisfaction with the treatment.

The following hypotheses were tested:

* The application of additional opiate boli results in significantly lower pain intensity.

* The application of additional opiate boli does not result in a higher rate of adverse Events.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-12
• Study Completion: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-23
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• chronic pain syndrome
• intrathecal opiate pump
• signed informed consent

Exclusion Criteria

• younger than 18 years
• other (than opiate) intrathecal drug administration
• discontent with intrathecal opiate therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
opiate without bolus	opiate with bolus	continuous opiate administration without bolus application
opiate with bolus	opiate with bolus	continuous opiate administration with additional bolus application

Primary Outcome Measures

Name	Time	Method
change in pain intensity	day 0. day 14, day 28	numeric rating scale from 0 to10

Secondary Outcome Measures

Name	Time	Method
change in satisfaction with treatment outcome	day 0, day 14, day 28	numeric rating scale from 0 to 10
side effects	from day 0 to day 28	occurrence rate of side effects