Vertebral SubluxationATLANTENCT04729049
Erector Spinae Block vs Morphine in Vertebral Fixation
A study testing Erector Spinae plane Block in people with Vertebral Subluxation and Spine Disease, run by AUSL Romagna Rimini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vertebral Subluxation, Spine Disease, Spondylolisthesis
- What is being tested?
- Erector Spinae plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 1 Jun 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II-III
- written informed consent signed
- traumatic or degenerative disease
- adult age (18-65 year old)
Who cannot join
- allergies to local anesthetics
- contraindications to ESP block execution
- congenital or drug-induced coagulopathies
- infections at the puncture site
- BMI > 40
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Vertebral Subluxation, Spine Disease, Spondylolisthesis
- Being tested
- Erector Spinae plane Block, Patient controlled analgesia with intravenous morphine
- Keywords
- Anesthesia, Postoperative Pain, Postoperative Delirium, Postoperative Nausea and Vomiting, Erector Spine plane Block, Neuraxial anesthesia
- Medical subject headings
- Spinal Diseases, Spondylolisthesis, Pain, Postoperative, Emergence Delirium, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae plane BlockProcedure or surgery
Also called ATLANTE
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.
Patient controlled analgesia with intravenous morphineDrug
Also called ATLANTE
Patient-controlled intermittent boluses of morphine 1 mg (maximum once every 15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Erector Spinae plane Block; Drug: 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. Receives: Drug: Patient controlled analgesia with intravenous morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
Milligrams of morphine used to control postoperative pain
Measured: 48 hours
Secondary outcomes (5)
Intraoperative opioid use
Micrograms of fentanyl used to control intraoperative pain
Measured: Intraoperative
Postoperative pain control
Numeric Rating Scale (NRS) 0= better outcome; 10=worse outcome
Measured: 2-6-12-24-36-48 postoperative hours
Postoperative agitation-sedation-delirium
Richmond agitation-sedation scale RASS -5 Cannot be arouse; 4 Combative
Measured: 2-6-12-24-36-48 postoperative hours
Patients satisfaction
1 (bad) to 10 (good) scale vote
Measured: at 48 postoperative hours
In-hospital length-of-stay
Number of days
Measured: 2-6-12-24-36-48 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vertebral SubluxationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cases vs control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUSL Romagna Rimini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Domenico P Santonastaso, MD, Principal investigator, AUSL Romagna - Ospedale Bufalini di Cesena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729049
- Sponsor's protocol ID
- 1220
- Acronym
- ATLANTE
- Status last verified
- Mar 2023
- First submitted
- 25 Jan 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data.
Publications
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.
PubMed 30621377Singh 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.
PubMed 29965831Singh 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.
PubMed 31033625Ueshima 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.
PubMed 30424594Bellantonio 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.
PubMed 37254058
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04729049
- Acronym / sponsor ID
- ATLANTE / 1220
- Conditions
- Vertebral Subluxation, Spine Disease, Spondylolisthesis
- Keywords
- Anesthesia, Postoperative Pain, Postoperative Delirium, Postoperative Nausea and Vomiting, Erector Spine plane Block, Neuraxial anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AUSL Romagna RiminiUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 28 Jan 2021 (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.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cases vs control
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block + patient controlled analgesia (PCA) with intravenous morphine | Experimental | Procedure: Erector Spinae plane Block, Drug: Patient controlled analgesia with intravenous morphinePreoperative 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. |
| Patient controlled analgesia (PCA) with intravenous morphine | Active comparator | Drug: Patient controlled analgesia with intravenous morphineEnd-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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-II-III
- written informed consent signed
- traumatic or degenerative disease
- adult age (18-65 year old)
Key exclusion criteria (5 listed)
- allergies to local anesthetics
- contraindications to ESP block execution
- congenital or drug-induced coagulopathies
- infections at the puncture site
- BMI > 40
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 |
|---|---|---|
| Erector Spinae plane BlockAlso: ATLANTEUltrasound-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. | Procedure or surgery | Erector spinae plane block + patient controlled analgesia (PCA) with intravenous morphine |
| Patient controlled analgesia with intravenous morphineAlso: ATLANTEPatient-controlled intermittent boluses of morphine 1 mg (maximum once every 15 minutes). | Drug | Erector spinae plane block + patient controlled analgesia (PCA) with intravenous morphine, Patient controlled analgesia (PCA) with intravenous morphine |
Primary outcome
Postoperative morphine consumption
Time frame: 48 hours
Milligrams of morphine used to control postoperative pain
5 secondary outcomes
Intraoperative opioid use
Time frame: Intraoperative
Postoperative pain control
Time frame: 2-6-12-24-36-48 postoperative hours
Postoperative agitation-sedation-delirium
Time frame: 2-6-12-24-36-48 postoperative hours
Patients satisfaction
Time frame: at 48 postoperative hours
In-hospital length-of-stay
Time frame: 2-6-12-24-36-48 postoperative hours
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 7 Mar 2023.
- Background: PubMed 30621377De 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.
- Background: PubMed 29965831Singh 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.
- Background: PubMed 31033625Singh 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.
- Background: PubMed 30424594Ueshima 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.
- Derived from this study: PubMed 37254058Bellantonio 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.
- Individual participant dataSharing planned: Yes. All data.
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.
Domenico P Santonastaso, MD principal investigator
AUSL Romagna - Ospedale Bufalini di Cesena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae plane Block in people with Vertebral Subluxation and Spine Disease, run by AUSL Romagna Rimini at 1 site in Italy.
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 5 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 7 Mar 2023. 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 Italy. 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?
Postoperative morphine consumption (time frame: 48 hours). 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 NCT04729049, which also lists 5 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 7 Mar 2023.