Effects of the Modification of the Daily Flow Rate with a Constant Daily Dose on Patient's Reported Analgesia in Intathecal Therapy - Effect of Daily Intrathecal Flow Rate on Analgesia

Phase 1

• Conditions: Chronic Pain.; MedDRA version: 8.1 Level: LLT Classification code 10049475 Term: Chronic pain

• Registration Number: EUCTR2006-002565-39-GB
• Lead Sponsor: South Tees Acute Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Study Completion: 2011-12-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients consenting to take part int he study.
2. Patients who are implanted with Synchromed Pump with a daily drug dose making it possible for the dose to be delivered in twice and four times the dilution within the flow limitation of the Synchromed system (0.048-1.4ml/day)
3. Clinical indication for intrathecal therapy
4. Patients able and willing to attend the pain clinic for three extra refills at two weekly intervals.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient refusal to take part int he study
2. Haemodynamic instability
3. Unable to fill in the diary for physical or psychological reasons.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Intrathecal (spinal) infusion devices are used in the management of chronic pain. This clinical trial aims to study the effect of the daily volume infused on the adequacy of pain relief as reported by patients on these infusion systems. We propose to alter the concentration of medication used int he patients and thereby the volume infused and study the effects. The absolute amount (dosage/day) of medication will remain unaltered.;Secondary Objective: We also intend to report on number of Patient Therapy Manager boluses used by each group and any reduction in systemic medication.;Primary end point(s): The outcome of the study is to determine the optimum concentration and volume of medications used in intrathecal therapy that provides the optimum pain relief for the patients.