- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01094912
Procedures of Locoregional Analgesia and Quality of Life in Palliative Care Units (TALViSoP)
Procedures of Locoregional Analgesia and Quality of Life in Palliative Care
Number of patients in mobile palliative care units have pain of both nociceptive and neuropathic origin. In certain cases, procedures of locoregional analgesia can be helpful.
The Purpose of this study is to evaluate the impact of techniques of locoregional analgesia in a palliative population
Study Overview
Detailed Description
Cancer pain is a serious problem in the palliative population. In particular, pain due to compression or invasion of nerve tissue by metastasis is frequent and often unresponsive to oral drug therapy and even to epidural administration of opioids. In such refractory pain in a palliative setting, one modality that could be helpful is the use of technics of locoregional analgesia. Currently, they are routinely used for the management of acute postoperative pain and become to be more widely used for cancer surgery. For example, intrapleural intercostal nerve blocks after major lung resection or preincisional paravertebral blocks after breast surgery have been shown to improve pain control. However, locoregional analgesia is only occasionally used in chronic cancer pain.
The procedures used are epidural analgesia, rachianesthesia, or continuous nerve blocks. L-bupivacaine will be used. The procedure will be performed only if the injection test is positive.
The patients will be evaluated before and after the procedure, the patient being his/her own control. Evaluations will take place immediately before the procedure, then at 48 hours, 1 week and 1 month after the procedure.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bordeaux, France
- Centre Hospitalier Universitaire - Hôpital Saint André
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Châteauroux, France
- Centre Hospitalier de Chateauroux
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Guéret, France
- Centre Hospitalier de Guéret
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Liomges, France
- CHU Limoges
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Saint Leonard de Noblat, France
- Centre Hospitalier Local
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Tulle, France
- Centre Hospitalier de Tulle
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient ≥ 18 years-old, male or female, whatever his/her ethnic group
- Patient with untreatable cancer
- Patient hospitalized in a palliative care unit, with a life expectancy ≥ 1 week
- Pain unresponsive to conventional treatments
- Effectiveness of the injection test
- Signed informed consent
Exclusion Criteria:
- Patients > 18 years-old
- Patients with pain other than cancer pain
- Patient's refusal
- Coagulation disorders
- Local infection
- Known hypersensitivity to local analgesics
- Inefficacy of the injection test.
- Contraindication for analgesics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patients global quality of life
Time Frame: 1 week after first injection
|
To evaluate the change in patients global quality of life, assessed by the item 15 of the validated quality of life scale EORTC QLQ-C15 PAL.
Evaluations will take place before the procedure of locoregional analgesia and 1 week after.
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1 week after first injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in patient's global quality of life
Time Frame: 2 days and 1 week after procedure
|
|
2 days and 1 week after procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gérard TERRIER, MD, CHU Limoges
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I08014/TALViSoP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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