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

Sponsor
University Hospital, Limoges (Other)
Overall Status
Suspended
CT.gov ID
NCT01094912
Collaborator
(none)
38
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Procedures of Locoregional Analgesia and Quality of Life in Palliative Care
Study Start Date :
Apr 1, 2010
Anticipated Primary Completion Date :
Oct 1, 2015
Anticipated Study Completion Date :
Oct 1, 2015

Outcome Measures

Primary Outcome Measures

  1. Change in patients global quality of life [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

  1. change in patient's global quality of life [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire - Hôpital Saint André Bordeaux France
2 Centre Hospitalier de Châteauroux Châteauroux France
3 Centre Hospitalier de Guéret Guéret France
4 CHU Limoges Liomges France
5 Centre Hospitalier Local Saint Leonard de Noblat France
6 Centre Hospitalier de Tulle Tulle France

Sponsors and Collaborators

  • University Hospital, Limoges

Investigators

  • Study Chair: Gérard TERRIER, MD, CHU Limoges

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01094912
Other Study ID Numbers:
  • I08014/TALViSoP
First Posted:
Mar 29, 2010
Last Update Posted:
Sep 1, 2015
Last Verified:
Mar 1, 2015
Keywords provided by University Hospital, Limoges
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2015