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AnalgesiaNESP-IINCT06070701

NOL-Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block

A study testing Superficial Parasternal Block (SIPB), Erector Spinae Plane Block (ESPB) and General anesthetic in people with Analgesia, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial focuses on an elaborate, propensity-matched, non-inferiority comparison of NOL-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Erector Spinae Plane Block (ESPB) within the context of open-heart surgery with cardiopulmonary bypass. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Analgesia
What is being tested?
Superficial Parasternal Block (SIPB), Erector Spinae Plane Block (ESPB) and General anesthetic
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteRomania
Study dates
1 Jun 2023to 1 Apr 2024
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed Consent.
  • Elective heart surgery with sternotomy and bypass.
  • Hemodynamic stability prior to induction.
  • Sinus rhythm.

Who cannot join

  • Known allergy to any of the medications used in the study.
  • BMI > 35.
  • Patient refusal to participate in the study.
  • Coagulopathy (INR > 1.5, APTT > 45, Fibrinogen < 150 mg/dl).
  • Non-elective/emergent and/or redo surgery.
  • ASA ≥ 4.
Show all 9Show fewer
  • Any preoperative hemodynamic support (mechanical or pharmaceutical).
  • Severe LV dysfunction (LVEF ≤ 30%).
  • Severe RV dysfunction.

Trial locations and contacts

1 site in 1 country.

Romania1 site
  • Cosmin Balan

    Bucharest, Sector 2, 022328

Other trials in Romania

About this study

Official title: NOL-Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Open Heart Surgery With Cardiopulmonary Bypass - A Propensity Matched Non-Inferiority Clinical Trial

This clinical trial focuses on an elaborate, propensity-matched, non-inferiority comparison of NOL-guided Superficial Parasternal Intercostal Plane Block (SPIPB) and Erector Spinae Plane Block (ESPB) within the context of open-heart surgery with cardiopulmonary bypass.

Read the detailed description
  1. Ethics

Local Ethics Committee approval and Informed Consent from patient or next-of-kin are obtained prior to study enrollment.

  1. Study enrollment

Forty consecutive adult patients scheduled for elective open cardiac surgery under general anesthesia are to receive general anesthesia plus SPIPB. This prospective group of patients will be matched one-to-one to a historical group of 55 patients that underwent open cardiac surgery under general anesthesia combined with ESPB.

  1. Methods

C1. Preinduction

  • 16-G peripheral intravenous cannula and radial artery catheter.
  • Five-lead ECG, pulse oximetry, non-invasive and invasive blood pressure monitoring.
  • Analgesia monitor - the NoL index (PMD200TM, Medasense) finger probe will be connected to the index finger of the non-cannulated hand.
  • Surgical antibiotic prophylaxis (Cefuroxime 1.5g).
  • Stress ulcer prophylaxis (omeprazole 40 mg).

C2. Superficial Parasternal Intercostal Plane Block (SPIPB)

After induction, skin asepsis with chlorhexidine 2% is performed on the anterior chest wall. A high-frequency linear ultrasound probe is positioned parasagittally, 2 cm from midline, bilaterally, at the level of the 4th rib. A 25-G echogenic block needle is inserted at a 20⁰-30⁰ angle in a caudal-to-cephalad direction until the tip of the needle reaches the interfascial plane between the pectoralis major muscle and the internal intercostal muscle. Correct hydrodissection is first certified using normal saline. Subsequently, ropivacaine 0.5% with dexamethasone 8mg/20ml is used and maximum spread is attained by slowly advancing the needle as the interfascial plane splits up ahead. A maximum dose of 3mg/kg ropivacaine is used, corresponding to 1.5 mg/kg per side (e.g., 20 ml ropivacaine 0.5% / side for a 70kg adult).

C3. General anaesthesia

Monitoring

  • End tidal CO2 (ETCO2).
  • Bispectral index (BIS) monitoring (target 40-60).
  • The nociception monitor (PMD200TM, Medasense) is started before induction.
  • CVP insertion into the right internal jugular vein under ultrasound guidance.
  • Urinary catheter, rectal temperature probe placement.

Induction

  • Propofol 1-1.5 mg/kg or Etomidate 0.2-0.3 mg/kg.
  • Fentanyl 5 mcg/kg.
  • Atracurium 0.5 mg/kg.

Maintenance of anaesthesia

  • Sevoflurane in O2 during periods of preserved pulmonary blood flow and mechanical ventilation.
  • Propofol infusion during periods of extracorporeal support.
  • Atracurium 0.2-0.3 mg/kg/h for adequate neuromuscular blockade.

Analgesia

  1. Analgesic drugs
  • Fentanyl: bolus 1.5 mcg/kg.
  • Paracetamol: 1-gram following induction of general anaesthesia.
  1. Analgesia monitoring
  • NoL index provides a multiderivative assessment of nociception before cardiopulmonary bypass (CPB) initiation. Optimal analgesia is defined as a NoL index of 10-25.
  • Mean arterial blood pressure (MAP) provides post-CPB decision loop: targets are within ± 15% of MAP recorded during optimum NOL.

C4. Postoperative

Extubation criteria

  • Normothermia (T◦ ≥ 36◦C).
  • No clinical bleeding.
  • Wakefulness.
  • Hemodynamic stability (MAP ≥ 60 mmHg and lactate ≤ 2 mmol/L) with minimal vasoactive support (dobutamine < 5 µg/kg/min and norepinephrine < 100 ng/kg/min).
  • Adequate gas exchange:
  • Tidal volume ≥ 5 ml/kg.
  • Adequate airway reflex to handle secretions.

Analgesia

  • Paracetamol 1g iv every 6 hours.
  • Morphine bolus 0.03 mg/kg for NRS > 3.
Conditions
Analgesia
Being tested
Superficial Parasternal Block (SIPB), Erector Spinae Plane Block (ESPB), General anesthetic, Morphine
Keywords
cardiac surgery, regional anesthesia, nociception, enhanced rehabilitation, erector spinae plane block, superficial parasternal intercostal plane block
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Superficial Parasternal Block (SIPB)Procedure or surgery

    Immediately after induction of general anesthesia, ropivacaine 0.5% with dexamethasone 8mg/20ml (maximum dose 1.5 mg/kg ropivacaine per each side) is administered in the superficial parasternal intercostal plane using real-time ultrasound guidance.

  • Erector Spinae Plane Block (ESPB)Procedure or surgery

    Immediately after induction of general anesthesia, ropivacaine 0.5% with dexamethasone 8mg/20ml (maximum dose 1.5 mg/kg ropivacaine per each side) is administered in the plane deep to the erector spinae muscle, typically at the level of the 5th thoracic vertebra, under real-time ultrasound guidance.

  • General anestheticDrug

    Also called NOL-directed general anesthesia

    During general anesthesia, fentanyl is administered according to NOL monitoring.

  • MorphineDrug

    Also called Postoperative analgesia

    Morphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4.

Study groups in NCT06070701
Study groupRoleWhat they receive
SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB)ExperimentalFollowing induction, ropivacaine 0.5% (1.5 mg/kg per each side) with dexamethasone 8mg/20ml is deposited under ultrasound guidance in the plane between the intercostal muscles and the pectoralis major muscles, targeting the anterior cutaneous branches of the intercostal nerves.
Receives: Procedure: Superficial Parasternal Block (SIPB); Drug: General anesthetic; Drug: Morphine
ERECTOR SPINAE PLANE BLOCK (ESPB)Active comparatorBefore induction, ropivacaine 0.5% (1.5 mg/kg per each side) with dexamethasone 8mg/20ml is deposited under ultrasound guidance between the transverse process of the 5th thoracic vertebra and the erector spinae muscle, targeting the dorsal and ventral rami of the spinal nerves.
Receives: Procedure: Erector Spinae Plane Block (ESPB); Drug: General anesthetic; Drug: Morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fentanyl consumption (µg/kg)

    Intraoperative opioid consumption after goal directed monitoring of nociception with the NOL index

    Measured: during intraoperative period

  2. Morphine consumption (µg/kg)

    Postoperative opioid consumption

    Measured: 48 hours after surgery

Secondary outcomes (9)
  1. Quality of postoperative analgesia

    Assessment - numerical rating scale (NRS) (minimum of 0, maximum of 10)

    Measured: 6 hours, 12 hours, 24 hours and 48 hours after extubation/ICU admission and 1 hour after drain removal

  2. Time to extubation

    Following ICU admission, the time it takes to extubate the patient safely

    Measured: up to 24 hours after surgery

  3. Norepinephrine dose (mcg/kg)

    Cumulative dose of Norepinephrine

    Measured: intraoperative, 6 hours and 12 hours after surgery

  4. Time to weaning-off norepinephrine

    Following ICU admission, the time it takes to stop norepinephrine administration

    Measured: up to 96 hours after surgery

  5. Dobutamine dose (mcg/kg)

    Cumulative dose of Dobutamine

    Measured: intraoperative, 6 hours and 12 hours after surgery

  6. Time to first dose of morphine

    Following admission, the time it takes a patient to request morphine rescue analgesia

    Measured: any time for 48 hours

  7. Extubated patients

    Number of extubated patients after ICU admission

    Measured: 2 hours after surgery

  8. Norepinephrine-free patients

    Number of patients without norepinephrine support

    Measured: 2 hours after surgery

  9. Morphine-free patients

    Number of patients who did not require morphine rescue analgesia

    Measured: 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2023
  2. Study start1 Jun 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Apr 2024

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Propensity score matching
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06070701
Sponsor's protocol ID
21330
Acronym
NESP-II
Status last verified
Apr 2024
First submitted
22 Sep 2023
Last updated
29 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Balan C, Tomescu DR, Valeanu L, Morosanu B, Stanculea I, Coman A, Stoian A, Bubenek-Turconi SI. Nociception Level Index-Directed Erector Spinae Plane Block in Open Heart Surgery: A Randomized Controlled Clinical Trial. Medicina (Kaunas). 2022 Oct 16;58(10):1462. doi: 10.3390/medicina58101462.

    PubMed 36295622
  • Balan C, Tomescu DR, Bubenek-Turconi SI. Nociception Control of Bilateral Single-Shot Erector Spinae Plane Block Compared to No Block in Open Heart Surgery-A Post Hoc Analysis of the NESP Randomized Controlled Clinical Trial. Medicina (Kaunas). 2023 Jan 30;59(2):265. doi: 10.3390/medicina59020265.

    PubMed 36837467

Questions about this trial

What is this clinical trial studying?

A study testing Superficial Parasternal Block (SIPB), Erector Spinae Plane Block (ESPB) and General anesthetic in people with Analgesia, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 1 site in Romania.

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 4 inclusion and 9 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: finished, as of the sponsor's last update on 29 Apr 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 Romania. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Fentanyl consumption (µg/kg) (time frame: during intraoperative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06070701, which also lists 2 linked publications.

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 29 Apr 2024.

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