NCT07427888

Treatment of Cancer Pain Using an Implantable Intrathecal Pump

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness and safety of an implantable intrathecal pump for the treatment of cancer-related pain compared with standard subcutaneous analgesic infusion. Cancer-related pain can be difficult to control with systemic opioid therapy and is often associated with significant side effects and reduced quality of life. Implantable intrathecal pumps allow direct delivery of analgesic medication into the intrathecal space, enabling effective pain control with lower drug doses and fewer systemic adverse effects. The study compares pain intensity, symptom burden, medication requirements, and quality of life in patients receiving analgesia via an implantable intrathecal pump versus those treated with a subcutaneous pump. The results of this study aim to support the introduction of implantable intrathecal pumps into routine clinical practice for selected patients with refractory cancer pain.

Detailed description

This prospective interventional clinical study investigates the use of an implantable intrathecal pump for the management of refractory cancer-related pain. Patients with advanced malignant disease and insufficient pain control despite optimized systemic opioid therapy are included. Participants are assigned to one of two treatment approaches: implantation of an intrathecal pump for continuous intrathecal delivery of analgesic medication, or standard care using a subcutaneous infusion pump delivering equipotent analgesic doses. Analgesic regimens are adjusted according to clinical response and patient needs. Pain intensity is assessed using validated pain scales, and symptom burden is monitored regularly. Quality of life is evaluated using standardized questionnaires at baseline and during follow-up. Additional outcomes include opioid consumption, adverse events, and patient satisfaction with pain management. The study is conducted at a single tertiary oncology center and follows ethical principles outlined in the Declaration of Helsinki. All participants provide written informed consent prior to enrollment. Findings from this study are intended to inform clinical decision-making and support the integration of implantable intrathecal pumps into standard oncological pain management.

Conditions

• Cancer Pain
• Neoplasm-Related Pain

Interventions

Type	Name	Description
DEVICE	Subcutaneous Analgesic Pump	Subcutaneous infusion pump used for continuous delivery of analgesic medication in patients with cancer-related pain.
DEVICE	Implantable Intrathecal Pump	Implantable intrathecal pump surgically implanted for continuous delivery of analgesic medication into the intrathecal space for management of refractory cancer-related pain.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Slovenia