NCT01094912

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
38

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable pain

Geographic Reach
1 country

6 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

March 1, 2015

Enrollment Period

5.5 years

First QC Date

March 26, 2010

Last Update Submit

August 31, 2015

Conditions

Keywords

Cancer pain

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • change in patient's global quality of life

    2 days and 1 week after procedure

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre Hospitalier Universitaire - Hôpital Saint André

Bordeaux, France

Location

Centre Hospitalier de Châteauroux

Châteauroux, France

Location

Centre Hospitalier de Guéret

Guéret, France

Location

CHU Limoges

Liomges, France

Location

Centre Hospitalier Local

Saint-Léonard-de-Noblat, France

Location

Centre Hospitalier de Tulle

Tulle, France

Location

MeSH Terms

Conditions

PainCancer Pain

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Gérard TERRIER, MD

    CHU Limoges

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2010

First Posted

March 29, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-03

Locations