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Erector Spinae Block vs Morphine in Vertebral Fixation (ATLANTE)

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ClinicalTrials.gov Identifier: NCT04729049
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
AUSL Romagna Rimini

Study Description
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Brief Summary:
The study aims to shed light about the potential role of Erector Spinae Block in the management of postoperative pain following vertebral fixation surgery via posterior approach. Patients will be randomized, the block will be performed before inducing general anesthesia, intraoperative management will be uniformed, while postoperative analgesia will compare cases (patients who received the block) versus controls (usual care with endovenous morphine infusion only).

Condition or disease Intervention/treatment Phase
Vertebral Subluxation Spine Disease Spondylolisthesis Procedure: Erector Spinae plane Block Drug: Patient controlled analgesia with intravenous morphine Not Applicable

Detailed Description:

The study is a single-centre, interventional, prospective, case-control study. After being informed about the study and potential risks during preoperative anaesthetic evaluation, all patients giving written informed consent will be enrolled in the study.

Inclusion criteria will be: patients undergoing vertebral fixation via posterior approach, age 18-85, American Society of Anesthesiologists (ASA) I-III, written informed consent signed. Exclusion criteria will be: traumatic spine injury, patients outside the 18-85 year old range, allergies or contraindications to the use of local anaesthetics and erector spinae block, skin infections at the puncture site, body-mass index above 40.

The estimated amount of patients needed to detect statistically significant results has been estimated in 60 (30 cases versus 30 controls). Considering the surgical activity in the organising centre, the study should be completed before the end of 2021. Randomization will be made with a random sequence informatically produced. The study will be single-blinded, with the physician making the postoperative pain optimization not knowing the type of anaesthesia performed.

Erector spine plane (ESP) block will be performed 30 minutes before general anaesthesia (GA) induction and the anaesthetic level will be assessed (pin-prick and hot-cold test). It will be made at the vertebral level of anaesthesia, bilaterally, with Ropivacaine 0.4% and dexamethasone 4 mg in 20 mL of sodium chloride (NaCl) 0.9% per side. GA will be induced with propofol, fentanyl and rocuronium to all patients, while GA maintenance will be performed with total-intravenous anaesthesia (TIVA) with propofol and boluses of fentanyl as required. Basic blood pressure, pulse-oximetry, electrocardiogram, train-of-four, body temperature and bispectral index monitoring will be applied to every patient. At the end of the surgery all the patients will receive a bolus of acetaminophen 1 g and morphine 6 mg.

Post-operative analgesia in controls will be performed by patient-controlled analgesia (PCA) pumps infusing boluses-at-request of morphine 1 mg (maximum once every 15 minutes) plus acetaminophen 1 g every 8 hours for the first 48 hours.

Post-operative analgesia in cases will be performed with PCA only releasing boluses-at-request (maximum 1 mg every 15 minutes) and acetaminophen 1 g every 8 hours during the first 48 hours.

Postoperative pain will be assessed by a trained physician blinded to the anaesthetic technique employed. Numerical rating scale (NRS) and Richmond agitation-sedation scale (RASS) will be performed at 2-6-12-24-36-48 hours after the end of the surgery.

The primary outcome is postoperative morphine consumption. Secondary outcomes are intraoperative opioid use, postoperative NRS scores, nausea and vomit (PONV), in-hospital length-of-stay and final patient satisfaction.

Statistical analysis will be performed by trained professionals with STATA 14.2 for Windows.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cases vs control
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

Patient and care provider (anaesthetist) will know the type of anaesthesia performed.

Outcome assessor (physician visiting the patient postoperatively) and investigator (study design and data analysis) will not know the type of anaesthesia performed.
Primary Purpose: Supportive Care
Official Title: Erector Spinae Plane Block Efficacy Versus Intravenous Morphine for Postoperative Pain Control Following Vertebral Fixation Surgery Via Posterior Approach: a Randomized Controlled Trial
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Erector spinae plane block + patient controlled analgesia (PCA) with intravenous morphine Procedure: Erector Spinae plane Block
Ultrasound-guided interfascial technique, aiming to block the anterior and posterior branches of the spinal nerves for multi-dermatomal analgesia. Injection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve a craniocaudal distribution along several vertebral levels.

Drug: Patient controlled analgesia with intravenous morphine
Patient-controlled intermittent boluses of morphine 1 mg (maximum once every 15 minutes).
Active Comparator: Patient controlled analgesia (PCA) with intravenous morphine Drug: Patient controlled analgesia with intravenous morphine
Patient-controlled intermittent boluses of morphine 1 mg (maximum once every 15 minutes).


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative morphine consumption [ Time Frame: 48 hours ]
    Milligrams of morphine used to control postoperative pain


Secondary Outcome Measures :
  1. Intraoperative opioid use [ Time Frame: Intraoperative ]
    Micrograms of fentanyl used to control intraoperative pain

  2. Postoperative pain control [ Time Frame: 2-6-12-24-36-48 postoperative hours ]
    Numeric Rating Scale (NRS) 0= better outcome; 10=worse outcome

  3. Postoperative nausea and vomit [ Time Frame: 2-6-12-24-36-48 postoperative hours ]
    Quantity of antiemetic drugs required to control nausea and vomiting episodes

  4. Postoperative agitation-sedation-delirium [ Time Frame: 2-6-12-24-36-48 postoperative hours ]
    Richmond agitation-sedation scale RASS -5 Cannot be arouse; 4 Combative

  5. Patients satisfaction [ Time Frame: 2-6-12-24-36-48 postoperative hours ]
    1 (bad) to 10 (good) scale vote

  6. In-hospital length-of-stay [ Time Frame: 2-6-12-24-36-48 postoperative hours ]
    Number of days


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II-III
  • written informed consent signed

Exclusion Criteria:

  • traumatic vertebral injuries
  • allergies to local anesthetics
  • contraindications to ESP block execution
  • congenital or drug-induced coagulopathies
  • infections at the puncture site
  • BMI > 40
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729049


Contacts
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Contact: Domenico P Santonastaso, MD 0547352818 ext +39 domenicopietro.santonastaso@auslromagna.it
Contact: Giuliano Bolondi, MD,MSc 0547352818 ext +39 med.bolondi@gmail.com

Locations
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Italy
AUSL Romagna M. Bufalini Hospital Recruiting
Cesena, Emilia Romagna, Italy, 47521
Contact: Domenico Pietro Santonastaso, MD    0547352818    domenicopietro.santonastaso@auslromagna.it   
Principal Investigator: Domenico Pietro Santonastaso, MD         
Sponsors and Collaborators
AUSL Romagna Rimini
More Information
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Publications:

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Responsible Party: AUSL Romagna Rimini
ClinicalTrials.gov Identifier: NCT04729049    
Other Study ID Numbers: 1220
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 5 years, after publication.
Access Criteria: Corresponding author email, upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AUSL Romagna Rimini:
Anesthesia
Postoperative Pain
Postoperative Delirium
 Postoperative Nausea and Vomiting
Erector Spine plane Block
Neuraxial anesthesia
Additional relevant MeSH terms:
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Spondylolisthesis
Spinal Diseases
Spondylolysis
Spondylosis
Bone Diseases
Musculoskeletal Diseases
Morphine
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents