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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Limoges
Information provided by (Responsible Party):
University Hospital, Limoges Identifier:
First received: March 26, 2010
Last updated: July 20, 2014
Last verified: July 2014

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: Endpoint Classification: Efficacy Study
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 ] [ 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 38
Study Start Date: April 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01094912

Contact: Gerard TERRIER, MD

Centre Hospitalier Universitaire - Hôpital Saint André Recruiting
Bordeaux, France
Contact: Benoît BURUCOA, MD    05 56 79 58 58   
Principal Investigator: Benoît BURUCOA, MD         
Centre Hospitalier de Châteauroux Not yet recruiting
Châteauroux, France
Contact: Hervé MIGNOT, MD    02 54 08 00 72   
Principal Investigator: Hervé MIGNOT, MD         
Centre Hospitalier de Guéret Recruiting
Guéret, France
Contact: Jean-Marc BOURDEREAU, MD    05 55 51 87 65      
Principal Investigator: Jean-Marc BOURDEREAU, MD         
CHU Limoges Recruiting
Liomges, France
Contact: Gérard TERRIER, MD    05 55 05 66 13   
Principal Investigator: Gérard TERRIER, MD         
Sub-Investigator: Dominique GROUILLE, MD         
Centre Hospitalier Local Recruiting
Saint Leonard de Noblat, France
Contact: Jean Luc LASSALLE, MD    05 55 56 43 02   
Principal Investigator: Jean Luc LASSALLE, MD         
Centre Hospitalier de Tulle Recruiting
Tulle, France
Contact: Philippe MADDALENO, MD    05 55 29 80 74   
Principal Investigator: Philippe MADDALENO, MD         
Sponsors and Collaborators
University Hospital, Limoges
Study Chair: Gérard TERRIER, MD CHU Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges Identifier: NCT01094912     History of Changes
Other Study ID Numbers: I08014/TALViSoP
Study First Received: March 26, 2010
Last Updated: July 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
Cancer pain processed this record on March 26, 2015