Procedures of Locoregional Analgesia and Quality of Life... | NCT01094912

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

NCT01094912

Sponsor

University Hospital, Limoges

Status

Suspended

Last Update Posted

Sep 1, 2015Estimated

Enrollment

38Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

opioids

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Oct 2015Estimated

Completion Date

Oct 2015Estimated

First Submitted Date

Mar 26, 2010

First Submission Date that Met QC Criteria

Mar 26, 2010

First Posted Date

Mar 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2015

Last Update Posted Date

Sep 1, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Name	Type	Description	Arm Group Labels	Other Names
opioids	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gérard TERRIER, MD	CHU Limoges	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire - Hôpital Saint André		Bordeaux			France
Centre Hospitalier de Châteauroux

Type	Date	Date Unknown
Release	Oct 9, 2018
Reset	Feb 20, 2019

Submission Tracking

Estimated Results First Submitted Date

Oct 9, 2018

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 9, 2018			Feb 20, 2019

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D000072716	Cancer Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000701	Analgesics, Opioid

Ancestor Terms

ID	Term
D009294	Narcotics
D002492	Central Nervous System Depressants
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided