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

Not Applicable

Suspended

• Conditions: Pain

• Registration Number: NCT01094912
• Lead Sponsor: University Hospital, Limoges

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 Timeline

• Study First Submitted: 2010-03-26
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Study Start: 2010-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in patients global quality of life	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.

Secondary Outcome Measures

Name	Time	Method
change in patient's global quality of life	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

Trial Locations

Locations (6)

Centre Hospitalier de Guéret; 🇫🇷 Guéret, France

CHU Limoges; 🇫🇷 Liomges, France

Centre Hospitalier Universitaire - Hôpital Saint André; 🇫🇷 Bordeaux, France

Centre Hospitalier de Châteauroux; 🇫🇷 Châteauroux, France

Centre Hospitalier Local; 🇫🇷 Saint Leonard de Noblat, France

Centre Hospitalier de Tulle; 🇫🇷 Tulle, France