PainTALViSoPNCT01094912
Procedures of Locoregional Analgesia and Quality of Life in Palliative Care Units
A study testing opioids in people with Pain, run by University Hospital, Limoges at 6 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- opioids
- How many people
- 38 participants
- Where
- 6 sitesFrance
- Study dates
- Apr 2010to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Hospitalier Universitaire - Hôpital Saint André
Bordeaux
Centre Hospitalier de Châteauroux
Châteauroux
Centre Hospitalier de Guéret
Guéret
CHU Limoges
Liomges
Centre Hospitalier Local
Saint-Léonard-de-Noblat
Centre Hospitalier de Tulle
Tulle
About this study
Official title: Procedures of Locoregional Analgesia and Quality of Life in Palliative Care
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
Read the 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.
- Conditions
- Pain
- Being tested
- opioids
- Keywords
- Cancer pain
- Medical subject headings
- Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioidsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after first injection
Secondary outcomes (1)
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
Measured: 2 days and 1 week after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gérard TERRIER, MD, Study chair, CHU Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094912
- Sponsor's protocol ID
- I08014/TALViSoP
- Acronym
- TALViSoP
- Status last verified
- Mar 2015
- First submitted
- 26 Mar 2010
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedures of Locoregional Analgesia and Quality of Life in Palliative Care
- ClinicalTrials.gov ID
- NCT01094912
- Acronym / sponsor ID
- TALViSoP / I08014/TALViSoP
- Conditions
- Pain
- Keywords
- Cancer pain
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Patients > 18 years-old
- Patients with pain other than cancer pain
- Patient's refusal
- Coagulation disorders
- Local infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| opioids | Drug | – |
Primary outcome
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.
1 secondary outcome
change in patient's global quality of life
Time frame: 2 days and 1 week after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gérard TERRIER, MD study chair
CHU Limoges
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing opioids in people with Pain, run by University Hospital, Limoges at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patients global quality of life (time frame: 1 week after first injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.