Procedures of Locoregional Analgesia and Quality of Life in Palliative Care Units (TALViSoP)
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|ClinicalTrials.gov Identifier: NCT01094912|
Recruitment Status : Suspended
First Posted : March 29, 2010
Last Update Posted : September 1, 2015
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|
|Pain||Drug: opioids||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|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 :||April 2010|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
- Change in patients global quality of life [ Time Frame: 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.
- change in patient's global quality of life [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094912
|Centre Hospitalier Universitaire - Hôpital Saint André|
|Centre Hospitalier de Châteauroux|
|Centre Hospitalier de Guéret|
|Centre Hospitalier Local|
|Saint Leonard de Noblat, France|
|Centre Hospitalier de Tulle|
|Study Chair:||Gérard TERRIER, MD||CHU Limoges|