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The efficacy, safety and cost-effectiveness analysis of morphine and hydromorphone in intrathecal drug deliver system for intractable cancer pain

The efficacy, safety and cost-effectiveness analysis of morphine and hydromorphone in intrathecal drug deliver system for intractable cancer pain:a multicenter, randomized single-blind, controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17751043
Enrollment
240
Registered
2016-01-26
Start date
2015-12-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Cancer pain Cancer

Interventions

An intrathecal catheter is placed at the L4/5 or L3/4 level and the catheter is passed under fluoroscopic guidance to the T10 or T11 vertebral level. Then, a tunneled subcutaneous catheter plus a subc

Sponsors

Chinese association for the study of pain, the minimally invasive interventional group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Cancer pain

Exclusion criteria

Exclusion criteria: 1. Researchers think that there is any reason can't include 2. IDDS procedure contraindications 3. Uncooperative and unable to finish the self evaluation (PHQ - 9, GAD - 7 and SF-36) 4. Spinal deformity, intolerance to operation 5. The central infection, severe systemic infection 6. The blood coagulation dysfunction; severe liver and kidney dysfunction 7. Patient who has a history of drug abuse

Design outcomes

Primary

MeasureTime frame
1. Pain after treatment, measured using the visual analogue score (VAS) every day during 3 months after treatment 2. Drug cost-effectiveness at 1, 2 and 3 months after treatment

Secondary

MeasureTime frame
1. The frequency, duration and degree of the flare pain everyday during 3 months after treatment 2. Intensity of anxiety experienced by patient. measured using the PHQ - 9 evaluation scale at 1, 2 and 3months after treatment 3. Intensity of depression experienced by patient, measured by the GAD - 7 anxiety screening scale) at 1, 2 and 3months after treatment 4. Quality of life measured by the quality of life score (SF - 36) at 1, 2 and 3 months after treatment

Countries

China

Outcome results

None listed

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