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

This study is currently recruiting participants.
Verified November 2013 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01094912
First received: March 26, 2010
Last updated: November 4, 2013
Last verified: November 2013

March 26, 2010
November 4, 2013
April 2010
December 2013   (final data collection date for primary outcome measure)
Change in patients global quality of life [ Time Frame: 1 week after first injection ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01094912 on ClinicalTrials.gov Archive Site
change in patient's global quality of life [ Time Frame: 2 days and 1 week after procedure ] [ Designated as safety issue: No ]
  • 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
Same as current
Not Provided
Not Provided
 
Procedures of Locoregional Analgesia and Quality of Life in Palliative Care Units
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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Pain
Drug: opioids
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
38
April 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Gerard TERRIER, MD gerard.terrier@chu-limoges.fr
France
 
NCT01094912
I08014/TALViSoP
No
University Hospital, Limoges
University Hospital, Limoges
Not Provided
Study Chair: Gérard TERRIER, MD CHU Limoges
University Hospital, Limoges
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP