Erector Spinae Block vs Morphine in Vertebral Fixation (ATLANTE)

Erector Spinae Plane Block Efficacy Versus Intravenous Morphine for Postoperative Pain Control Following Vertebral Fixation Surgery Via Posterior Approach: a Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Spondylolisthesis; Spine Disease; Vertebral Subluxation
• Intervention / Treatment: Procedure: Erector Spinae plane Block; Drug: Patient controlled analgesia with intravenous morphine

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 both for degenerative or traumatic causes, age 18-85, American Society of Anesthesiologists (ASA) I-III, written informed consent signed. Exclusion criteria will be: 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 initial estimate of patients needed to detect statistically significant results has been estimated in 30 (15 cases versus 15 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 double-blinded, with the patient, the nurse doing the postoperative pain assessment and the statisticians not knowing the type of anaesthesia performed (only the anesthesist in the operating theatre is unblinded).

Erector spine plane (ESP) block will be performed after general anaesthesia (GA) induction, with the patient already in prone position. It will be made at the vertebral level of surgical fixation, 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 4 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) with no background infusion, 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, in-hospital length-of-stay and final patient satisfaction.

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Emilia Romagna
    • Cesena, Emilia Romagna, Italy, 47521
      • AUSL Romagna M. Bufalini Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I-II-III
• written informed consent signed
• traumatic or degenerative disease
• adult age (18-65 year old)

Exclusion Criteria:

• allergies to local anesthetics
• contraindications to ESP block execution
• congenital or drug-induced coagulopathies
• infections at the puncture site
• BMI > 40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector spinae plane block + patient controlled analgesia (PCA) with intravenous morphine; Preoperative bilateral ESP block with ropivacaine 0,4% + dexamethasone 4 mg, 20 mL per side, at the median spinal level of intervention. End-surgery: acetaminophen 1 g ev + 4 mg morphine ev before the end of the intervention. PCA: morphine 1 mg, max every 30 minutes. Rescue: ketoprofen 100 mg ev, max three times per day.	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.; Other Names: ATLANTE; Drug: Patient controlled analgesia with intravenous morphine; Patient-controlled intermittent boluses of morphine 1 mg (maximum once every 15 minutes).; Other Names: ATLANTE
Active Comparator: Patient controlled analgesia (PCA) with intravenous morphine; End-surgery: acetaminophen 1 g ev + 4 mg morphine ev before the end of the intervention. PCA: morphine 1 mg, max every 30 minutes. Rescue: ketoprofen 100 mg ev, max three times per day.	Drug: Patient controlled analgesia with intravenous morphine; Patient-controlled intermittent boluses of morphine 1 mg (maximum once every 15 minutes).; Other Names: ATLANTE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morphine consumption	Milligrams of morphine used to control postoperative pain	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative opioid use	Micrograms of fentanyl used to control intraoperative pain	Intraoperative
Postoperative pain control	Numeric Rating Scale (NRS) 0= better outcome; 10=worse outcome	2-6-12-24-36-48 postoperative hours
Postoperative agitation-sedation-delirium	Richmond agitation-sedation scale RASS -5 Cannot be arouse; 4 Combative	2-6-12-24-36-48 postoperative hours
In-hospital length-of-stay	Number of days	2-6-12-24-36-48 postoperative hours
Patients satisfaction	1 (bad) to 10 (good) scale vote	at 48 postoperative hours

Collaborators and Investigators

• Sponsor: AUSL Romagna Rimini
• Investigators: Principal Investigator: Domenico P Santonastaso, MD, AUSL Romagna - Ospedale Bufalini di Cesena

Publications and helpful links

General Publications

• Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.
• Ueshima H, Inagaki M, Toyone T, Otake H. Efficacy of the Erector Spinae Plane Block for Lumbar Spinal Surgery: A Retrospective Study. Asian Spine J. 2019 Apr;13(2):254-257. doi: 10.31616/asj.2018.0114. Epub 2018 Nov 15.
• De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
• Singh S, Chaudhary NK. Bilateral Ultasound Guided Erector Spinae Plane Block for Postoperative Pain Management in Lumbar Spine Surgery: A Case Series. J Neurosurg Anesthesiol. 2019 Jul;31(3):354. doi: 10.1097/ANA.0000000000000518. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Pain; Postoperative Nausea and Vomiting; Anesthesia; Postoperative Delirium; Neuraxial anesthesia; Erector Spine plane Block
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spinal Diseases; Spondylolisthesis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 1220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data.
• IPD Sharing Time Frame: 5 years, after publication.
• IPD Sharing Access Criteria: Corresponding author email, upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No