NCT04729049

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

January 25, 2021

Last Update Submit

March 6, 2023

Conditions

Vertebral SubluxationSpine DiseaseSpondylolisthesis

Keywords

AnesthesiaPostoperative PainPostoperative DeliriumPostoperative Nausea and VomitingErector Spine plane BlockNeuraxial anesthesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative morphine consumption

    Milligrams of morphine used to control postoperative pain

    48 hours

Secondary Outcomes (5)

  • Intraoperative opioid use

    Intraoperative

  • Postoperative pain control

    2-6-12-24-36-48 postoperative hours

  • Postoperative agitation-sedation-delirium

    2-6-12-24-36-48 postoperative hours

  • Patients satisfaction

    at 48 postoperative hours

  • In-hospital length-of-stay

    2-6-12-24-36-48 postoperative hours

Study Arms (2)

Erector spinae plane block + patient controlled analgesia (PCA) with intravenous morphine

EXPERIMENTAL

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 BlockDrug: Patient controlled analgesia with intravenous morphine

Patient controlled analgesia (PCA) with intravenous morphine

ACTIVE COMPARATOR

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

Interventions

Erector Spinae plane BlockPROCEDURE

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.

Also known as: ATLANTE
Erector spinae plane block + patient controlled analgesia (PCA) with intravenous morphine
Patient controlled analgesia with intravenous morphineDRUG

Patient-controlled intermittent boluses of morphine 1 mg (maximum once every 15 minutes).

Also known as: ATLANTE
Erector spinae plane block + patient controlled analgesia (PCA) with intravenous morphinePatient controlled analgesia (PCA) with intravenous morphine

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AUSL Romagna M. Bufalini Hospital

Cesena, Emilia-Romagna, 47521, Italy

Location

Related Publications (5)

  • 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.

    PMID: 30621377BACKGROUND

  • 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.

    PMID: 29965831BACKGROUND

  • 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.

    PMID: 31033625BACKGROUND

  • 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.

    PMID: 30424594BACKGROUND

  • Bellantonio D, Bolondi G, Cultrera F, Lofrese G, Mongardi L, Gobbi L, Sica A, Bergamini C, Viola L, Tognu A, Tosatto L, Russo E, Santonastaso DP, Agnoletti V. Erector spinae plane block for perioperative pain management in neurosurgical lower-thoracic and lumbar spinal fusion: a single-centre prospective randomised controlled trial. BMC Anesthesiol. 2023 May 30;23(1):187. doi: 10.1186/s12871-023-02130-z.

    PMID: 37254058DERIVED

MeSH Terms

Conditions

Spinal DiseasesSpondylolisthesisPain, PostoperativeEmergence DeliriumPostoperative Nausea and Vomiting

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosisPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsDeliriumConfusionNeurobehavioral ManifestationsNervous System DiseasesNeurocognitive DisordersMental DisordersNauseaSigns and Symptoms, DigestiveVomiting

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Domenico P Santonastaso, MD

    AUSL Romagna - Ospedale Bufalini di Cesena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Cases vs control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 28, 2021

Study Start

February 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

All data.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
5 years, after publication.
Access Criteria
Corresponding author email, upon reasonable request.

Locations

IT(1)