Intrathecal Analgesia Effects on Cancer Patients Discomfort Symptoms

Evaluation of Discomfort Symptoms in Patients With Refractory Cancer Pain and Intrathecal Analgesia Management

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04491123

Acronym

IT-ESAS

Enrollment

Registered

2020-07-29

Start date

2018-11-01

Completion date

2020-06-30

Last updated

2020-07-29

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

Conditions

Intrathecal Analgesia, Refractory Cancer Pain

Keywords

Refractory cancer pain, intrathecal analgesia, pain management, discomfort symptoms management

Brief summary

Intrathecal analgesia is used in refractory cancer pain because of drug sides effects or intractable pain. The aim of this approach is to improve pain management, and also to improve patient comfort. This study will assess patient discomfort symptoms before and after setting up intrathecal analgesia.

Detailed description

Descriptive multicenter study including patients with refractory cancer pain (unmanageable drug sides effects or intractable pain) who will receive intrathecal analgesia Patient discomfort symptoms will be evaluated before and after the beginning of intrathecal analgesia at 15, 30, 60 and 90 days. Moreover, the impact on patient close relatives and on return home will be assessed.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients aged 18 and older * obligation of affiliation or beneficiary of a social security scheme * patients with cancer and refractory localized cancer pain because of drug side effects or intractable pain * localized pain in topography accessible to intrathecal analgesia (legs, abdomen and pelvis, pancoast-tobias symdrom) * patient's informed consent for the study * patient able to complete the evaluation questionnaires * estimed vital prognosis more than three month * patient with all conditions for intrathecal anagelsia

Exclusion criteria

* patient with intracranial hypertension * refusal of patient to be included in the study * refusal of patient to receive intrathecal analgesia * patient with many refractory pain localizations not accessible to intrathecal analgesia

Design outcomes

Primary

Measure	Time frame	Description
Number Evaluation of Edmonton symptoms	up to 90 days after patient inclusion	Edmonton symptom assessment system

Secondary

Measure	Time frame	Description
Autonomy assessment score for activities of daily living	1 day	Autonomy assessment score for activities of daily living

Countries

France

Outcome results