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

NCT02197741 | Completed

• 1 other identifier: 2014-15
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• change in pain intensity

  numeric rating scale from 0 to10

  day 0. day 14, day 28

Secondary Outcomes (2)

• change in satisfaction with treatment outcome

  day 0, day 14, day 28

• side effects

  from day 0 to day 28

Study Arms (2)

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

Interventions

opiate with bolus DRUG

opiate with bolus; opiate without bolus

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

individuals with chronic pain syndrome

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

MeSH Terms

Interventions

Opiate Alkaloids

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Tim Reck, MD

  Center for Pain Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 23, 2014
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2014
• Last Updated: November 22, 2016

Record last verified: 2016-11