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

Chronic Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197741
• Other study ID #: 2014-15
• Status: Completed
• Phase: N/A
• First received: July 4, 2014
• Last updated: November 21, 2016
• Start date: February 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2016
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome

Intervention

Drug:
• opiate with bolus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in pain intensity	numeric rating scale from 0 to10	day 0. day 14, day 28	No
Secondary	change in satisfaction with treatment outcome	numeric rating scale from 0 to 10	day 0, day 14, day 28	No
Secondary	side effects	occurrence rate of side effects	from day 0 to day 28	No