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

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: Chronic Pain Syndrome
• Intervention / Treatment: Drug: opiate with bolus

• Study Type: Observational
• Enrollment (Actual): 10

Participation Criteria

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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

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	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	numeric rating scale from 0 to 10	day 0, day 14, day 28
side effects	occurrence rate of side effects	from day 0 to day 28

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Centre Nottwil
• Investigators: Principal Investigator: Tim Reck, MD, Center for Pain Medicine

Study record dates

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: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Opiate Alkaloids
• Other Study ID Numbers: 2014-15