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Completed

NCT Number: NCT04491123

Intrathecal Analgesia Effects on Cancer Patients Discomfort Symptoms

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.

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Key information

Conditions

Refractory Cancer Pain Agnosia Cancer Pain Intrathecal Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number Evaluation of Edmonton symptoms

    Time frame: up to 90 days after patient inclusion

    Edmonton symptom assessment system

Secondary outcomes

  1. Autonomy assessment score for activities of daily living

    Time frame: 1 day

    Autonomy assessment score for activities of daily living

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Centre Hospitalier Universitaire de Nīmes
  • Institut du Cancer de Montpellier - Val d'Aurelle
  • Oncopole Toulouse

Registry information

Official study title

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

Acronym: IT-ESAS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2020
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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