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

NCT ID: NCT02197741

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Chronic Pain Syndrome

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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opiate without bolus

continuous opiate administration without bolus application

opiate with bolus

Intervention Type DRUG

opiate with bolus

continuous opiate administration with additional bolus application

opiate with bolus

Intervention Type DRUG

Interventions

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opiate with bolus

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim Reck, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Pain Medicine

Other Identifiers

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2014-15

Identifier Type: -

Identifier Source: org_study_id