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

This study is currently recruiting participants.

Verified February 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: February 27, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 26, 2010

Last Updated Date

February 27, 2013

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01094912 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Procedures of Locoregional Analgesia and Quality of Life in Palliative Care

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: opioids

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gerard TERRIER, MD

gerard.terrier@chu-limoges.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01094912

Other Study ID Numbers ^ICMJE

I08014/TALViSoP

Has Data Monitoring Committee

Responsible Party

University Hospital, Limoges

Study Sponsor ^ICMJE

University Hospital, Limoges

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Gérard TERRIER, MD

CHU Limoges

Information Provided By

University Hospital, Limoges

Verification Date

February 2013

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

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