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.
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.
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
- Ethics
Local Ethics Committee approval and Informed Consent from patient or next-of-kin are obtained prior to study enrollment.
- 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.
- 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
- Analgesic drugs
- Fentanyl: bolus 1.5 mcg/kg.
- Paracetamol: 1-gram following induction of general anaesthesia.
- 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 group | Role | What they receive |
|---|---|---|
| SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB) | Experimental | Following 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 comparator | Before 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.
Fentanyl consumption (µg/kg)
Intraoperative opioid consumption after goal directed monitoring of nociception with the NOL index
Measured: during intraoperative period
Morphine consumption (µg/kg)
Postoperative opioid consumption
Measured: 48 hours after surgery
Secondary outcomes (9)
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
Time to extubation
Following ICU admission, the time it takes to extubate the patient safely
Measured: up to 24 hours after surgery
Norepinephrine dose (mcg/kg)
Cumulative dose of Norepinephrine
Measured: intraoperative, 6 hours and 12 hours after surgery
Time to weaning-off norepinephrine
Following ICU admission, the time it takes to stop norepinephrine administration
Measured: up to 96 hours after surgery
Dobutamine dose (mcg/kg)
Cumulative dose of Dobutamine
Measured: intraoperative, 6 hours and 12 hours after surgery
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
Extubated patients
Number of extubated patients after ICU admission
Measured: 2 hours after surgery
Norepinephrine-free patients
Number of patients without norepinephrine support
Measured: 2 hours after surgery
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.
- First posted6 Oct 2023
- Study start1 Jun 2023
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balan Ion Cosmin, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Investigators
- Serban-Ion Bubenek-Turconi, Professor, Study director, "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
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 36295622Balan 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06070701
- Acronym / sponsor ID
- NESP-II / 21330
- Conditions
- Analgesia
- Keywords
- cardiac surgery, regional anesthesia, nociception, enhanced rehabilitation, erector spinae plane block, superficial parasternal intercostal plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. IliescuUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 6 Oct 2023 (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.
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.
Detailed description
- Ethics
Local Ethics Committee approval and Informed Consent from patient or next-of-kin are obtained prior to study enrollment.
- 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.
- 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
- Analgesic drugs
- Fentanyl: bolus 1.5 mcg/kg.
- Paracetamol: 1-gram following induction of general anaesthesia.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Propensity score matching
| Arm | Type | Receives |
|---|---|---|
| SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB) | Experimental | Procedure: Superficial Parasternal Block (SIPB), Drug: General anesthetic, Drug: MorphineFollowing 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. |
| ERECTOR SPINAE PLANE BLOCK (ESPB) | Active comparator | Procedure: Erector Spinae Plane Block (ESPB), Drug: General anesthetic, Drug: MorphineBefore 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent.
- Elective heart surgery with sternotomy and bypass.
- Hemodynamic stability prior to induction.
- Sinus rhythm.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Superficial Parasternal Block (SIPB)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. | Procedure or surgery | SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB) |
| Erector Spinae Plane Block (ESPB)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. | Procedure or surgery | ERECTOR SPINAE PLANE BLOCK (ESPB) |
| General anestheticAlso: NOL-directed general anesthesiaDuring general anesthesia, fentanyl is administered according to NOL monitoring. | Drug | ERECTOR SPINAE PLANE BLOCK (ESPB), SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB) |
| MorphineAlso: Postoperative analgesiaMorphine 0.03 mg/kg is administered postoperatively for NRS scores equal or higher than 4. | Drug | ERECTOR SPINAE PLANE BLOCK (ESPB), SUPERFICIAL PARASTERNAL INTERCOSTAL PLANE BLOCK (SPIPB) |
Primary outcome
Fentanyl consumption (µg/kg)
Time frame: during intraoperative period
Intraoperative opioid consumption after goal directed monitoring of nociception with the NOL index
Morphine consumption (µg/kg)
Time frame: 48 hours after surgery
Postoperative opioid consumption
9 secondary outcomes
Quality of postoperative analgesia
Time frame: 6 hours, 12 hours, 24 hours and 48 hours after extubation/ICU admission and 1 hour after drain removal
Time to extubation
Time frame: up to 24 hours after surgery
Norepinephrine dose (mcg/kg)
Time frame: intraoperative, 6 hours and 12 hours after surgery
Time to weaning-off norepinephrine
Time frame: up to 96 hours after surgery
Dobutamine dose (mcg/kg)
Time frame: intraoperative, 6 hours and 12 hours after surgery
Time to first dose of morphine
Time frame: any time for 48 hours
Extubated patients
Time frame: 2 hours after surgery
Norepinephrine-free patients
Time frame: 2 hours after surgery
Morphine-free patients
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Results publication: PubMed 36295622Balan 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.
- Results publication: PubMed 36837467Balan 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.
- Individual participant dataSharing planned: No
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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.
Serban-Ion Bubenek-Turconi, Professor study director
"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
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.