AnesthesiaPABLOS2NCT06534775
PABLOS 2.0 - Chronic Pain After Sternotomy
An observational study of Anesthesia, run by University Hospital, Angers at 1 site in France.
Trial summary
The PABLOS study (NCT05345639) recently realised at the University Hospital of Angers looked at the place of loco-regional anesthesia (LRA) in the optimization of analgesia and the early post-operative recovery of patients operated from cardiac surgery by sternotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Questionnary
- How many people
- 253 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2024to 18 Aug 2025
- Phase
- Observational
- 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
Study population: Patients from the PABLOS study, without non-inclusion criteria, are pre-selected to participate in the study. These are patients from the original PABLOS study who underwent thoracic surgery by sternotomy at the Angers University Hospital. The PABLOS inclusion period extended from August 1, 2022 to August 2, 2023. Patients receive an information letter at home, containing all the information relating to the PABLOS 2.0 study, a few weeks before receiving a telephone call, as well as a booklet containing the questionnary. From this stage, the patient has the possibility of contacting the team to express their opposition to participating in the study.
Who may be able to join
- Patient who participated in the PABLOS study (See below);
- French-speaking patient, able to understand and answer a questionnary
Who cannot join
- Patient who has had an operation for cardiac or thoracic surgery, including a REDUX (surgical revision) of sternotomy since their inclusion in the PABLOS study;
- Patient opposing the research.
- PABLOS criteria (NCT05345639) :
- Pre-inclusion criteria
- Adult patient (≥18 years old);
- Patient having planned cardiac surgery with performance of a sternotomy at the Angers University Hospital;
Show all 24Show fewer
- Patient having signed consent;
- French-speaking patient, able to understand and answer a questionnary;
- Patient affiliated to or beneficiary of a social security scheme;
- Criteria for confirming inclusion
- Hemodynamic stability at the end of surgical intervention;
- Absence of bleeding justifying immediate surgical revision
- Non-inclusion criteria
- Known hypersensitivity to local anesthetics with amide bonds;
- Operation for cardiac surgical revision, including REDUX (surgical revision) of sternotomy;
- Emergency surgery;
- Surgery in a septic context (Endocarditis, Intravascular device infection);
- Weight less than 30kg;
- Severe psychiatric or cognitive disorder hindering assessment by questionnary;
- Pregnant, breastfeeding or parturient woman;
- Person deprived of liberty by judicial or administrative decision;
- Person subject to psychiatric care under duress;
- Person subject to a legal protection measure;
- Inclusion in another interventional study modifying post-operative pain management.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Dr Achille DEMARQUETTE
Angers, Maine Et Loire, 49933
Achille DEMARQUETTE, Dr, (0)2 41 35 39 51 ext. 33, Achille.Demarquette@chu-angers.fr
Maxime LEGER, Dr, (0)2 41 34 00 83 ext. 33, Maxime.Leger@chu-angers.fr
About this study
Official title: PABLOS 2.0 - Chronic Pain After Sternotomy, Prospective Non-interventional Study
The PABLOS study (NCT05345639) recently realised at the University Hospital of Angers looked at the place of loco-regional anesthesia (LRA) in the optimization of analgesia and the early post-operative recovery of patients operated from cardiac surgery by sternotomy.
All randomized patients (n=253) were followed for 30 days as part of PABLOS monitoring with the aim of optimizing acute care.
Read more
However, sternotomy surgery causes chronic pain with neuropathic components. Indeed, numerous recent studies suggest that cardiac surgery by median sternotomy is associated with the development of chronic sternal pain with an incidence of 11% to 56% one year after surgery. Most patients with chronic post-sternotomies pain report mild pain (1 to 3 on the Numerical Scale), however, up to 18% report moderate to severe pain (4 to 10 on the EN).
It therefore seems important to the investigator to evaluate the prevalence of chronic post-sternotomies pain within our PABLOS cohort and to know whether performing a post-operative LRA limits their occurrence.
Read the detailed description
PABLOS 2.0 is a non-interventional cohort study with prospective data collection by telephone questionnary, with three groups from a single-center superiority interventional study. Patients remained blinded for the duration of the study.
The patients in the cohort come from the precedent PABLOS study (NCT05345639). They receive oral and written information, and confirm orally their non-opposition to participating in the PABLOS 2.0 study.
The specific procedures of the PABLOS 2.0 study are the collection using a telephone questionnary of the score of the numerical scale (from 0 to 10) of pain at rest and with effort, of the DN4 (proportion of chronic pain with a neuropathic component), of the EQ-5D-5L scale (quality of life) and of consumption of painkillers.
- Conditions
- Anesthesia
- Being tested
- Questionnary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaryOther
The patients were included in a previous study (PABLOS) - These patients received locoregional anesthesia (LRA) by deep parasternal intercostal block (Deep-PIP) or bilateral superficial parasternal intercostal block (Superficial-PIP), compared with standard management (general anesthesia without LRA) for chronic postoperative pain after cardiac surgery by sternotomy.
In PABLOS 2.0 study, the evaluation focuses on the presence of chronic pain between 12 and 24 months postoperatively. There is no intervention in PABLOS 2.0 study but only a questionnary.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of LRA
The main objective is to compare the effectiveness of LRA (bilateral transverse thoracic block or bilateral parasternal block) compared to standard management (general anesthesia without LRA) on late postoperative recovery after surgery heart by sternotomy.
The main endpoint is defined by the presence at the time of the call of pain that has been evolving for > 3 months with a numerical scale >0. Self-assessment by numerical scale varies from 0 to 10 :
- 0 being no pain
- from 1 to 3 : mild pain
- from 4 to 6 : moderate pain
- from 7 to 10 : severe pain
Measured: 12 to 24 months
Secondary outcomes (7)
LRA Impact on the intensity of exercise pain
Exercise-induced pain self-assessed using a numerical scale ranging : 0, no pain, to 10, the maximum pain imaginable.(12 to 24 months depending on the date the interview was carried out) Pain location is taken into account : main location of the pain in predefined areas (back, head, thorax, saphenous harvest scar, abdomen)
Measured: 12 to 24 months
LRA Impact on the prevalence of neuropathic pain
Evaluate by the DN4 questionnary assessement. The patient must answer 10 questions divided into 4 items. If the patient's score is equal to or higher than 4/10, the test is positive.
Measured: 12 to 24 months
LRA Impact on daily consumption of analgesics
Evaluate by measurement of daily consumption of painkillers
Measured: 12 to 24 months
LRA Impact on quality of life
Quality of life measured using the EQ-5D-5L score.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression Each dimension have five response levels: no problems (score 1), slight problems, moderate problems, severe problems and extreme problems (score 5).
Higher scores mean a worse outcome
Responses are coded as single-digit numbers expressing the severity level selected in each dimension.
Measured: 12 to 24 months
To describe all-cause mortality in cardiac surgery patients
Measurement of prevalence of deaths since the end of PABLOS follow-up
Measured: 12 to 24 months
Infection of the puncture point(s) event in context of LRA in the long term.
During the telephone call, investigator will ask the patient if he/she has had an infection of the puncture site(s) after the initial PABLOS follow-up period (i.e. after 30 days post-operatively).
Measured: 12 to 24 months
sternotomy scar revision in context of LRA in the long term.
During the telephone call, investigator will ask the patient if he/she has the need for sternotomy scar revision after the initial PABLOS follow-up period (i.e. after 30 days post-operatively).
Measured: 12 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start19 Aug 2024
- Primary completion18 Aug 2025 (estimated)
- Study completion18 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 253 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534775
- Sponsor's protocol ID
- 49RC24_0179
- Acronym
- PABLOS2
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PABLOS 2.0 - Chronic Pain After Sternotomy, Prospective Non-interventional Study
- ClinicalTrials.gov ID
- NCT06534775
- Acronym / sponsor ID
- PABLOS2 / 49RC24_0179
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 253 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 18 Aug 2025 (estimated)
- Study completion
- 18 Aug 2025 (estimated)
- First posted
- 2 Aug 2024 (actual)
- 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.
The PABLOS study (NCT05345639) recently realised at the University Hospital of Angers looked at the place of loco-regional anesthesia (LRA) in the optimization of analgesia and the early post-operative recovery of patients operated from cardiac surgery by sternotomy.
All randomized patients (n=253) were followed for 30 days as part of PABLOS monitoring with the aim of optimizing acute care.
However, sternotomy surgery causes chronic pain with neuropathic components. Indeed, numerous recent studies suggest that cardiac surgery by median sternotomy is associated with the development of chronic sternal pain with an incidence of 11% to 56% one year after surgery. Most patients with chronic post-sternotomies pain report mild pain (1 to 3 on the Numerical Scale), however, up to 18% report moderate to severe pain (4 to 10 on the EN).
It therefore seems important to the investigator to evaluate the prevalence of chronic post-sternotomies pain within our PABLOS cohort and to know whether performing a post-operative LRA limits their occurrence.
Detailed description
PABLOS 2.0 is a non-interventional cohort study with prospective data collection by telephone questionnary, with three groups from a single-center superiority interventional study. Patients remained blinded for the duration of the study.
The patients in the cohort come from the precedent PABLOS study (NCT05345639). They receive oral and written information, and confirm orally their non-opposition to participating in the PABLOS 2.0 study.
The specific procedures of the PABLOS 2.0 study are the collection using a telephone questionnary of the score of the numerical scale (from 0 to 10) of pain at rest and with effort, of the DN4 (proportion of chronic pain with a neuropathic component), of the EQ-5D-5L scale (quality of life) and of consumption of painkillers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the PABLOS study, without non-inclusion criteria, are pre-selected to participate in the study. These are patients from the original PABLOS study who underwent thoracic surgery by sternotomy at the Angers University Hospital. The PABLOS inclusion period extended from August 1, 2022 to August 2, 2023. Patients receive an information letter at home, containing all the information relating to the PABLOS 2.0 study, a few weeks before receiving a telephone call, as well as a booklet containing the questionnary. From this stage, the patient has the possibility of contacting the team to express their opposition to participating in the study.
Key inclusion criteria (2 listed)
- Patient who participated in the PABLOS study (See below);
- French-speaking patient, able to understand and answer a questionnary
Key exclusion criteria (24 listed)
- Patient who has had an operation for cardiac or thoracic surgery, including a REDUX (surgical revision) of sternotomy since their inclusion in the PABLOS study;
- Patient opposing the research.
- Pre-inclusion criteria
- Adult patient (≥18 years old);
- Patient having planned cardiac surgery with performance of a sternotomy at the Angers University Hospital;
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 |
|---|---|---|
| QuestionnaryThe patients were included in a previous study (PABLOS) - These patients received locoregional anesthesia (LRA) by deep parasternal intercostal block (Deep-PIP) or bilateral superficial parasternal intercostal block (Superficial-PIP), compared with standard management (general anesthesia without LRA) for chronic postoperative pain after cardiac surgery by sternotomy. In PABLOS 2.0 study, the evaluation focuses on the presence of chronic pain between 12 and 24 months postoperatively. There is no intervention in PABLOS 2.0 study but only a questionnary. | Other | – |
Primary outcome
Effectiveness of LRA
Time frame: 12 to 24 months
The main objective is to compare the effectiveness of LRA (bilateral transverse thoracic block or bilateral parasternal block) compared to standard management (general anesthesia without LRA) on late postoperative recovery after surgery heart by sternotomy. The main endpoint is defined by the presence at the time of the call of pain that has been evolving for > 3 months with a numerical scale >0. Self-assessment by numerical scale varies from 0 to 10 : * 0 being no pain * from 1 to 3 : mild pain * from 4 to 6 : moderate pain * from 7 to 10 : severe pain
7 secondary outcomes
LRA Impact on the intensity of exercise pain
Time frame: 12 to 24 months
LRA Impact on the prevalence of neuropathic pain
Time frame: 12 to 24 months
LRA Impact on daily consumption of analgesics
Time frame: 12 to 24 months
LRA Impact on quality of life
Time frame: 12 to 24 months
To describe all-cause mortality in cardiac surgery patients
Time frame: 12 to 24 months
Infection of the puncture point(s) event in context of LRA in the long term.
Time frame: 12 to 24 months
sternotomy scar revision in context of LRA in the long term.
Time frame: 12 to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University Hospital, Angers at 1 site 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 2 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Achille DEMARQUETTE, Dr (6 58 08 92 74 ext. 33, achille.demarquette@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of LRA (time frame: 12 to 24 months). 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 26 Aug 2024.