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

Pain Clinical Trial

— TALViSoP  

Official title:

Procedures of Locoregional Analgesia and Quality of Life in Palliative Care

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01094912
• Other study ID #: I08014/TALViSoP
• Status: Suspended
• Phase: N/A
• First received: March 26, 2010
• Last updated: August 31, 2015
• Start date: April 2010
• Est. completion date: October 2015

Study information

• Verified date: March 2015
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 38
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• opioids

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire - Hôpital Saint André	Bordeaux
France	Centre Hospitalier de Châteauroux	Châteauroux
France	Centre Hospitalier de Guéret	Guéret
France	CHU Limoges	Liomges
France	Centre Hospitalier Local	Saint Leonard de Noblat
France	Centre Hospitalier de Tulle	Tulle

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patients global quality of life	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.	1 week after first injection	No
Secondary	change in patient's global quality of life	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	2 days and 1 week after procedure	No