Intrathecal Analgesia Effects on Cancer Patients Discomfort Symptoms

NCT ID: NCT04491123

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Refractory Cancer Pain Intrathecal Analgesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role collaborator

Oncopole Toulouse

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphael RENAMBATZ-ICHAMBE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL19_0065

Identifier Type: -

Identifier Source: org_study_id

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