Duration of Hospitalization in Intensive Care UnitPARALSTERNCT06463899
Evaluation of the Effectiveness of the Administration of Local Anesthetics Via Two Catheters Placed During Surgery, and Study of the Benefits on Respiratory Function and Therefore on Recovery Time
A study testing multi-perforated catheter and Classic procedure in people with Duration of Hospitalization in Intensive Care Unit, run by CHU de Reims at 1 site in France.
Trial summary
Currently intravenous analgesics are used for postoperative analgesia. But the analgesia of these products is tempered by their adverse effects (sedation, confusion, nausea or vomiting, delayed transit, urinary retention and pruritus) which can slow down postoperative recovery. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Duration of Hospitalization in Intensive Care Unit
- What is being tested?
- multi-perforated catheter and Classic procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2023to 8 Feb 2026
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
This study will include adults over 18 years of age requiring on-pump coronary bypass surgery with at least one of the following respiratory risk factors:
- BMI > or = 30 Kg / m2
- Active or withdrawn smoking for less than 6 weeks
- COPD documented by pulmonologist or respiratory function test (LVEF/ FVC <0.7 not reversible after bronchodilator)
- Restrictive ventilatory disorders, defined by a CPT less than 80% of normal
- Chronic respiratory failure, defined by a PaO2, at rest, in ambient air, less than 70 mmHg
- Age > or = 75 years old exclusion criteria:
Any patient meeting one of the following criteria will be excluded from the study:
- Emergency surgery
- Other operative procedure planned during the same intervention (for example vascular), apart from the saphenous sample
- Aortic dissection
- Preoperative renal failure with GFR <30 mL / min / 1.73 m2
- Left heart failure with Ejection fraction <30%
- Pulmonary arterial hypertension> 50 mmHg
- Hepatic cytolysis with ALT or AST> 2N
- ASA score > or = 4
- Coagulopathy
- Anticoagulants or antiaggregants not stopped in time (according to usual protocols) or with poorly performed or unjustified relay
- Chronic use of opioids or history of drug addiction
- Progressive pregnancy or breastfeeding
- Inability to understand protocol and sign consent
- Known allergy to one of the substances in the study protocol
- Patients requiring assistance such as ECMO, intra-aortic counter pulsation balloon or Impella will be excluded from the protocol.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Salvadore MUCCIO, 03 10 73 66 50 ext. 0033, smuccio@chu-reims.fr
About this study
Official title: Impact of Bilateral Parasternal Infusion of Local Anesthetics in Patients With Respiratory Risk Factors Over the Length of Hospitalization and Morphine Sparing in the Intensive Care Unit After On-pump Coronary Bypass Surgery
Currently intravenous analgesics are used for postoperative analgesia. But the analgesia of these products is tempered by their adverse effects (sedation, confusion, nausea or vomiting, delayed transit, urinary retention and pruritus) which can slow down postoperative recovery.
The aim of this study is to evaluate the effectiveness of the administration of local anesthetics via two catheters placed during surgery, but also to study their benefit on respiratory function and therefore on recovery time and morphine sparing.
Read the detailed description
Medical context:
Cardiac surgery and more specifically coronary bypass surgery are very painful postoperative surgeries, especially during the first 48 hours following the operation. These pains, present at rest, are increased when the patient is mobilized, during coughing, deep inspiration, chairing or mobilization in bed.
In cardiac surgery, it has been shown that respiratory complications remain a significant cause of morbidity and mortality. They can lead to an extension of the length of hospitalization and therefore an increase in hospital costs. Indeed, these are increased compared to other surgeries because of the sternotomy and the pain it causes, as well as the type of ventilation during extracorporeal circulation (sharp reduction or even stopping of mechanical ventilation).
Patients having, prior to surgery, risk factors for postoperative respiratory complications, present increased risks of pneumonia, postoperative atelectasis, pleurisy, re-intubation, mortality and therefore an additional cost of hospitalization.
Limiting postoperative pain allows better rehabilitation of the patient by improving patient mobilization, participation in respiratory physiotherapy and therefore potentially a reduction in respiratory complications.
Currently, multimodal analgesia combining opioids, nefopam, nonsteroidal anti-inflammatory drugs, ketamine, lidocaine and paracetamol, is the most widely used technique in patients. The analgesic efficacy provided by opioids is tempered by their side effects (sedation, confusion, nausea or vomiting, transit delay, urinary retention, pruritus) which may slow postoperative recovery. In addition, opioids can also decrease the cough reflex and impair respiratory control.
It is therefore important to find alternatives to the analgesic management of these patients who, thanks to the improvement of surgical and anesthetic techniques, are more and more numerous.
The use of para-sternal catheters with bilateral infusion of local anesthetics has already shown its effectiveness in terms of reducing opioid consumption and safety. However, no benefit has yet been proven in terms of reducing the length of hospital stay in subjects at respiratory risk undergoing surgery such as on pump coronary bypass surgery.
Goal :
Show that the use of a bilateral para-sternal infusion of local anesthetics (ropivacaine 0.2%) by multi-perforated catheters in patients with respiratory risk factors who have undergone coronary bypass surgery, makes it possible to reduce the length of stay in an intensive care unit.
- Being tested
- multi-perforated catheter, Classic procedure
- Keywords
- para-sternal catheters, analgesia, coronary bypass surgery, sternotomy, hospitalization
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-perforated catheterProcedure or surgery
After skin closure, cardiac surgeons place multi-perforated catheters aseptically.
Classic procedureProcedure or surgery
opioid analgesia (PCA morphine in bolus mode alone or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol
| Study group | Role | What they receive |
|---|---|---|
| WITH catheter | Experimental | A "multi-perforated catheter" arm benefiting from opioid analgesia (Patient controlled Analgesia ((PCA)) morphine (bolus-only mode or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol associated with analgesia by continuous infusion of local anesthetics (ropivacaine) via two multi-perforated catheters Receives: Procedure: multi-perforated catheter |
| WITHOUT catheter | Active comparator | A "control" arm benefiting from opioid analgesia (PCA morphine in bolus mode alone or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol. Receives: Procedure: Classic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the duration of hospitalization in intensive care unit
Study of the benefit of the administration of local anesthetics via two catheters placed during surgery on recovery time versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects, and can slow down postoperative recovery.
Measured: Day 1
Secondary outcomes (4)
Evaluation of the pain at rest and on mobilization using a visual pain evaluation scale
Study of the effectiveness of the administration of local anesthetics via two catheters placed during surgery, including their benefit on respiratory function, versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects.
Measured: Day 2
Evaluation of the total consumption of opioids
Study of the use of local anesthetics via two catheters placed during surgery for morphine sparing versus the use of currently intravenous analgesics that are used for postoperative analgesia which are multimodal analgesia combining opioids like nefopam, nonsteroidal anti-inflammatory drugs, ketamine, lidocaine and paracetamol
Measured: At 48 hours
Evaluation of the patient mortality
Study of the benefit of the administration of local anesthetics via two catheters placed during surgery on respiratory function and complications which remains a significant cause of morbidity and mortality versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects.
Measured: Day 30
Evaluation of the occurrence of the side effects of opioids
Study of the benefit of the administration of local anesthetics via two catheters placed during surgery versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects as sedation, confusion, nausea or vomiting, delayed transit, urinary retention and pruritus.
Measured: At 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start8 Feb 2023
- Primary completion8 Nov 2025 (estimated)
- Study completion8 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duration of Hospitalization in Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463899
- Sponsor's protocol ID
- PO22011
- Acronym
- PARALSTER
- Status last verified
- Jun 2024
- First submitted
- 14 Aug 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bilateral Parasternal Infusion of Local Anesthetics in Patients With Respiratory Risk Factors Over the Length of Hospitalization and Morphine Sparing in the Intensive Care Unit After On-pump Coronary Bypass Surgery
- ClinicalTrials.gov ID
- NCT06463899
- Acronym / sponsor ID
- PARALSTER / PO22011
- Keywords
- para-sternal catheters, analgesia, coronary bypass surgery, sternotomy, hospitalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 8 Nov 2025 (estimated)
- Study completion
- 8 Feb 2026 (estimated)
- First posted
- 18 Jun 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.
Currently intravenous analgesics are used for postoperative analgesia. But the analgesia of these products is tempered by their adverse effects (sedation, confusion, nausea or vomiting, delayed transit, urinary retention and pruritus) which can slow down postoperative recovery.
The aim of this study is to evaluate the effectiveness of the administration of local anesthetics via two catheters placed during surgery, but also to study their benefit on respiratory function and therefore on recovery time and morphine sparing.
Detailed description
Medical context:
Cardiac surgery and more specifically coronary bypass surgery are very painful postoperative surgeries, especially during the first 48 hours following the operation. These pains, present at rest, are increased when the patient is mobilized, during coughing, deep inspiration, chairing or mobilization in bed.
In cardiac surgery, it has been shown that respiratory complications remain a significant cause of morbidity and mortality. They can lead to an extension of the length of hospitalization and therefore an increase in hospital costs. Indeed, these are increased compared to other surgeries because of the sternotomy and the pain it causes, as well as the type of ventilation during extracorporeal circulation (sharp reduction or even stopping of mechanical ventilation).
Patients having, prior to surgery, risk factors for postoperative respiratory complications, present increased risks of pneumonia, postoperative atelectasis, pleurisy, re-intubation, mortality and therefore an additional cost of hospitalization.
Limiting postoperative pain allows better rehabilitation of the patient by improving patient mobilization, participation in respiratory physiotherapy and therefore potentially a reduction in respiratory complications.
Currently, multimodal analgesia combining opioids, nefopam, nonsteroidal anti-inflammatory drugs, ketamine, lidocaine and paracetamol, is the most widely used technique in patients. The analgesic efficacy provided by opioids is tempered by their side effects (sedation, confusion, nausea or vomiting, transit delay, urinary retention, pruritus) which may slow postoperative recovery. In addition, opioids can also decrease the cough reflex and impair respiratory control.
It is therefore important to find alternatives to the analgesic management of these patients who, thanks to the improvement of surgical and anesthetic techniques, are more and more numerous.
The use of para-sternal catheters with bilateral infusion of local anesthetics has already shown its effectiveness in terms of reducing opioid consumption and safety. However, no benefit has yet been proven in terms of reducing the length of hospital stay in subjects at respiratory risk undergoing surgery such as on pump coronary bypass surgery.
Goal :
Show that the use of a bilateral para-sternal infusion of local anesthetics (ropivacaine 0.2%) by multi-perforated catheters in patients with respiratory risk factors who have undergone coronary bypass surgery, makes it possible to reduce the length of stay in an intensive care unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WITH catheter | Experimental | Procedure: multi-perforated catheterA "multi-perforated catheter" arm benefiting from opioid analgesia (Patient controlled Analgesia ((PCA)) morphine (bolus-only mode or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol associated with analgesia by continuous infusion of local anesthetics (ropivacaine) via two multi-perforated catheters |
| WITHOUT catheter | Active comparator | Procedure: Classic procedureA "control" arm benefiting from opioid analgesia (PCA morphine in bolus mode alone or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| multi-perforated catheterAfter skin closure, cardiac surgeons place multi-perforated catheters aseptically. | Procedure or surgery | WITH catheter |
| Classic procedureopioid analgesia (PCA morphine in bolus mode alone or morphine titration if PCA not available), nefopam, non-steroidal anti-inflammatory drugs, ketamine, pregabalin and paracetamol | Procedure or surgery | WITHOUT catheter |
Primary outcome
Evaluation of the duration of hospitalization in intensive care unit
Time frame: Day 1
Study of the benefit of the administration of local anesthetics via two catheters placed during surgery on recovery time versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects, and can slow down postoperative recovery.
4 secondary outcomes
Evaluation of the pain at rest and on mobilization using a visual pain evaluation scale
Time frame: Day 2
Evaluation of the total consumption of opioids
Time frame: At 48 hours
Evaluation of the patient mortality
Time frame: Day 30
Evaluation of the occurrence of the side effects of opioids
Time frame: At 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 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?
A study testing multi-perforated catheter and Classic procedure in people with Duration of Hospitalization in Intensive Care Unit, run by CHU de Reims 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?
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 13 Nov 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 Salvadore MUCCIO (03 10 73 66 50 ext. 0033, smuccio@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the duration of hospitalization in intensive care unit (time frame: Day 1). 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 13 Nov 2024.