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
  Purpose

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
Pain
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: April 2014
Estimated Primary Completion Date: December 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094912

Contacts
Contact: Gerard TERRIER, MD gerard.terrier@chu-limoges.fr

Locations
France
Centre Hospitalier Universitaire - Hôpital Saint André Recruiting
Bordeaux, France
Contact: Benoît BURUCOA, MD    05 56 79 58 58    benoit.burucoa@chu-bordeaux.fr   
Principal Investigator: Benoît BURUCOA, MD         
Centre Hospitalier de Châteauroux Not yet recruiting
Châteauroux, France
Contact: Hervé MIGNOT, MD    02 54 08 00 72    eadsp36@wanadoo.fr   
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    gerard.terrier@chu-limoges.fr   
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    jl.lassalle@medsyn.fr   
Principal Investigator: Jean Luc LASSALLE, MD         
Centre Hospitalier de Tulle Recruiting
Tulle, France
Contact: Philippe MADDALENO, MD    05 55 29 80 74    soinspalliatifs@ch-tulle.fr   
Principal Investigator: Philippe MADDALENO, MD         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Study Chair: Gérard TERRIER, MD CHU Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01094912     History of Changes
Other Study ID Numbers: I08014/TALViSoP
Study First Received: March 26, 2010
Last Updated: November 4, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
Cancer pain

Additional relevant MeSH terms:
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 17, 2014