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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002565-39-GB

Enrollment

Registered

2006-09-18

Start date

2006-11-27

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: Bupivacaine Hydrochloride Pharmaceutical Form: Solution for injection INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE CAS Number: 18010407

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026