ScoliosisNCT05944393
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
A study testing Ropivacaine 0.2% Injectable Solution and Normal saline 0.9% Injectable Solution in people with Scoliosis and Regional Anesthesia, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Postoperative pain after scoliosis correction surgery is severe and usually requires long-term intravenous opioid therapy. Local anesthetic options are limited and include intrathecal opioids and epidural analgesia. However, they are rarely used due to side effects and inconsistent efficacy. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Scoliosis, Regional Anesthesia, Pediatric Anesthesia
- What is being tested?
- Ropivacaine 0.2% Injectable Solution and Normal saline 0.9% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 8 Sep 2022to 30 Dec 2023
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients < 18 years old undergoing scoliosis surgery
Who cannot join
- refusal to participate
- > 18 yo
- Chronic opioid use
- localized infection
Trial locations and contacts
1 site in 1 country.
Małgorzata Domagalska contact
Poland1 site, 1 recruiting
- Recruiting
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
Poznan, Wielkopolska, 61-545
Tomasz Kotwicki, Profesor, +48618310157, kckod@ump.edu.pl
About this study
Postoperative pain after scoliosis correction surgery is severe and usually requires long-term intravenous opioid therapy. Local anesthetic options are limited and include intrathecal opioids and epidural analgesia. However, they are rarely used due to side effects and inconsistent efficacy. The investigators describe an opioid-sparing multimodal analgesia regimen with bilateral erector spinae plane blocks.
Read the detailed description
Posterior spinal fusion for scoliosis correction is extremely painful and usually requires long-term, high-dose opioid use for adequate perioperative analgesia. Neuromonitoring, i.e., motor-evoked and somatosensory-evoked potentials (SSEPs), are the current gold standard for preventing neurological damage. Local anesthesia is essential to multimodal analgesia, but options are limited. Intrathecal or epidural opioid injections of local anesthetics have been reported but are rarely used due to logistical complexity, side effects, and inconsistent analgesic efficacy. The erector spinae plane (ESP) block was first described in 2016 for thoracic neuropathic pain. It is a new interfacial plane technique. Easy to perform on patients without spinal deformities. It was successfully used for surgery in adults. However, even with ultrasound guidance, identifying bone markers in scoliosis patients is challenging. The investigators will treat patients for scoliosis with single-shot bilateral ESP blocks. The investigators aim to provide effective perioperative pain control and achieve intraoperative hemodynamic stability without compromising neuromonitoring.
- Being tested
- Ropivacaine 0.2% Injectable Solution, Normal saline 0.9% Injectable Solution
- Keywords
- erector spine plane block, neuromonitoring, pain management, multimodal analgesia
- Medical subject headings
- Scoliosis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable SolutionDrug
Ultrasound-guided Erector Spine Plane block with 10 mL 0.5% ropivacaine
Normal saline 0.9% Injectable SolutionDrug
Ultrasound-guided Erector Spine Plane block with 10 mL 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| ESB block | Experimental | Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0.2% ropivacaine per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,2% Ropivacaine. The needle is withdrawn, and the needle entry site is wiped clean. Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| Placebo block | Experimental | Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0,9% normal saline per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,9% normal saline. The needle is withdrawn, and the needle entry site is wiped clean. Receives: Drug: Normal saline 0.9% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Measured: Within 30 minutes of emergence from anesthesia
pain score - 60 minutes
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Measured: Within 60 minutes of emergence from anesthesia
pain score - 90 minutes
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Measured: Within 90 minutes of emergence from anesthesia
pain score - 120 minutes
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Measured: Within 120 minutes of emergence from anesthesia
pain score - 6 hours
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Measured: Within 6 hours of emergence from anesthesia
pain score - 12 hours
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Measured: Within 12 hours of emergence from anesthesia
pain score - 24 hours
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Measured: Within 24 hours of emergence from anesthesia
pain score - 48 hours
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Measured: Within 48 hours of emergence from anesthesia
Secondary outcomes (7)
total opioid consumption within first 24 hours
Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.
Measured: Second day following the procedure
opioid consumption - 48 hours
Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.
Measured: Within 48 hours of emergence from anesthesia
Nausea and Vomiting
This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit.
Measured: Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (0-48 hours postoperativly)
NLR -12 hours
neutrophil/limphocyte ratio
Measured: 12 hours postoperatively
PLR -12 hours
platelet/limphocyte ratio
Measured: 12 hours postoperatively
NLR - 24 hours
neutrophil/limphocyte ratio
Measured: 12 hours postoperatively
PLR - 24 hours
platelet/limphocyte ratio
Measured: 12 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start8 Sep 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- after being informed about the study and potential risks. All patients giving written consent will be randomized in a double-blind manner into 2 groups each one containing 25 patients, ESP group (n =25 ): The patients will receive Erector Spine Plane Block (ESP Block) after induction of general anesthesia. Control group (n =25 ): The patients will receive a placebo block after induction of general anesthesia
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Małgorzata Domagalska, PhD, Principal investigator, Department of Palliative Medicine, University of Medical SciencesTomasz Kotwicki, Profesor, Study chair, Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944393
- Sponsor's protocol ID
- 673/22
- Status last verified
- Jul 2023
- First submitted
- 19 Feb 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data presented in this study are available on request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
- ClinicalTrials.gov ID
- NCT05944393
- Acronym / sponsor ID
- 673/22
- Keywords
- erector spine plane block, neuromonitoring, pain management, multimodal analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Jul 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.
Postoperative pain after scoliosis correction surgery is severe and usually requires long-term intravenous opioid therapy. Local anesthetic options are limited and include intrathecal opioids and epidural analgesia. However, they are rarely used due to side effects and inconsistent efficacy. The investigators describe an opioid-sparing multimodal analgesia regimen with bilateral erector spinae plane blocks.
Detailed description
Posterior spinal fusion for scoliosis correction is extremely painful and usually requires long-term, high-dose opioid use for adequate perioperative analgesia. Neuromonitoring, i.e., motor-evoked and somatosensory-evoked potentials (SSEPs), are the current gold standard for preventing neurological damage. Local anesthesia is essential to multimodal analgesia, but options are limited. Intrathecal or epidural opioid injections of local anesthetics have been reported but are rarely used due to logistical complexity, side effects, and inconsistent analgesic efficacy. The erector spinae plane (ESP) block was first described in 2016 for thoracic neuropathic pain. It is a new interfacial plane technique. Easy to perform on patients without spinal deformities. It was successfully used for surgery in adults. However, even with ultrasound guidance, identifying bone markers in scoliosis patients is challenging. The investigators will treat patients for scoliosis with single-shot bilateral ESP blocks. The investigators aim to provide effective perioperative pain control and achieve intraoperative hemodynamic stability without compromising neuromonitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- after being informed about the study and potential risks. All patients giving written consent will be randomized in a double-blind manner into 2 groups each one containing 25 patients, ESP group (n =25 ): The patients will receive Erector Spine Plane Block (ESP Block) after induction of general anesthesia. Control group (n =25 ): The patients will receive a placebo block after induction of general anesthesia
| Arm | Type | Receives |
|---|---|---|
| ESB block | Experimental | Drug: Ropivacaine 0.2% Injectable SolutionPatients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0.2% ropivacaine per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,2% Ropivacaine. The needle is withdrawn, and the needle entry site is wiped clean. |
| Placebo block | Experimental | Drug: Normal saline 0.9% Injectable SolutionPatients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0,9% normal saline per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,9% normal saline. The needle is withdrawn, and the needle entry site is wiped clean. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients < 18 years old undergoing scoliosis surgery
Key exclusion criteria (4 listed)
- refusal to participate
- > 18 yo
- Chronic opioid use
- localized infection
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 |
|---|---|---|
| Ropivacaine 0.2% Injectable SolutionUltrasound-guided Erector Spine Plane block with 10 mL 0.5% ropivacaine | Drug | ESB block |
| Normal saline 0.9% Injectable SolutionUltrasound-guided Erector Spine Plane block with 10 mL 0.9% normal saline | Drug | Placebo block |
Primary outcome
pain score
Time frame: Within 30 minutes of emergence from anesthesia
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 60 minutes
Time frame: Within 60 minutes of emergence from anesthesia
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 90 minutes
Time frame: Within 90 minutes of emergence from anesthesia
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 120 minutes
Time frame: Within 120 minutes of emergence from anesthesia
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 6 hours
Time frame: Within 6 hours of emergence from anesthesia
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 12 hours
Time frame: Within 12 hours of emergence from anesthesia
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 24 hours
Time frame: Within 24 hours of emergence from anesthesia
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 48 hours
Time frame: Within 48 hours of emergence from anesthesia
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
7 secondary outcomes
total opioid consumption within first 24 hours
Time frame: Second day following the procedure
opioid consumption - 48 hours
Time frame: Within 48 hours of emergence from anesthesia
Nausea and Vomiting
Time frame: Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (0-48 hours postoperativly)
NLR -12 hours
Time frame: 12 hours postoperatively
PLR -12 hours
Time frame: 12 hours postoperatively
NLR - 24 hours
Time frame: 12 hours postoperatively
PLR - 24 hours
Time frame: 12 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: Yes. The data presented in this study are available on request from the corresponding author.
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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.
Małgorzata Domagalska contact
Małgorzata Domagalska, PhD principal investigator
Department of Palliative Medicine, University of Medical Sciences
Tomasz Kotwicki, Profesor study chair
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.2% Injectable Solution and Normal saline 0.9% Injectable Solution in people with Scoliosis and Regional Anesthesia, run by Poznan University of Medical Sciences at 1 site in Poland.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jul 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Małgorzata Domagalska, PhD (608762068, m.domagalska@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: Within 30 minutes of emergence from anesthesia). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2023.