Intrathecal Analgesia Effects on Cancer Patients Discomfort Symptoms

Refractory Cancer Pain Clinical Trial

— IT-ESAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491123
• Other study ID #: RECHMPL19_0065
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain
• Intrathecal Analgesia
• Refractory Cancer Pain

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Institut du Cancer de Montpellier, Nimes University Hospital, Oncopole Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Evaluation of Edmonton symptoms	Edmonton symptom assessment system	up to 90 days after patient inclusion
Secondary	Autonomy assessment score for activities of daily living	Autonomy assessment score for activities of daily living	1 day