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Procedures of Locoregional Analgesia and Quality of Life in Palliative Care Units (TALViSoP)

This study has suspended participant recruitment.
Information provided by (Responsible Party):
University Hospital, Limoges Identifier:
First received: March 26, 2010
Last updated: August 31, 2015
Last verified: March 2015

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

Condition Intervention
Drug: opioids

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Procedures of Locoregional Analgesia and Quality of Life in Palliative Care

Resource links provided by NLM:

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • change in patient's global quality of life [ Time Frame: 2 days and 1 week after procedure ]
    • evaluate the change in EORTC QLQ-C15 PAL score, assessed before the procedure of locoregional analgesia and 1 week after.
    • evaluate the change in patient's global quality of life, assessed by the item 15 of the validated quality of life scale EORTC QLQ-C15 PAL at 48 hours and 1 week post-procedure.
    • evaluate pain at 48 hours post-procedure
    • evaluate the change in doses of conventional treatments at 1 week

Estimated Enrollment: 38
Study Start Date: April 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01094912

Centre Hospitalier Universitaire - Hôpital Saint André
Bordeaux, France
Centre Hospitalier de Châteauroux
Châteauroux, France
Centre Hospitalier de Guéret
Guéret, France
CHU Limoges
Liomges, France
Centre Hospitalier Local
Saint Leonard de Noblat, France
Centre Hospitalier de Tulle
Tulle, France
Sponsors and Collaborators
University Hospital, Limoges
Study Chair: Gérard TERRIER, MD CHU Limoges
  More Information

Responsible Party: University Hospital, Limoges Identifier: NCT01094912     History of Changes
Other Study ID Numbers: I08014/TALViSoP
Study First Received: March 26, 2010
Last Updated: August 31, 2015

Keywords provided by University Hospital, Limoges:
Cancer pain processed this record on May 23, 2017