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

November 21, 2016 updated by: Swiss Paraplegic Centre Nottwil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

individuals with chronic pain syndrome

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
opiate without bolus
continuous opiate administration without bolus application
Drug: opiate with bolus
opiate with bolus
continuous opiate administration with additional bolus application
Drug: opiate with bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in pain intensity
Time Frame: day 0. day 14, day 28
numeric rating scale from 0 to10
day 0. day 14, day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in satisfaction with treatment outcome
Time Frame: day 0, day 14, day 28
numeric rating scale from 0 to 10
day 0, day 14, day 28
side effects
Time Frame: from day 0 to day 28
occurrence rate of side effects
from day 0 to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Centre Nottwil

Investigators

  • Principal Investigator: Tim Reck, MD, Center for Pain Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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