ScoliosisBBESPBNCT04697498
Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations
A study testing Bilateral bi-level Erector spine plane block and General anaesthesia in people with Scoliosis and Spinal Deformity, run by Lviv National Medical University at 1 site in Ukraine.
Trial summary
Improving the anesthesiology management for surgical correction of spinal deformations with introducing the diagnostic methods and treatment strategy of acute pain, preventing the evolution of chronic pain. Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Scoliosis, Spinal Deformity, Acute Pain
- What is being tested?
- Bilateral bi-level Erector spine plane block and General anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUkraine
- Study dates
- 16 Dec 2020to Dec 2025
- 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 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent of the patient or his legal representatives to participate the study.
- Spinal deformity that requires surgical correction.
- No known allergies to local anaesthetics.
- Negative intradermal test for sensitivity to local anaesthetics.
Who cannot join
- Refusal of the patient or his legal representatives to participate the study
- Diabetes mellitus, known allergy to local anaesthetics
- Acute spinal cord injury
- Physical status according to classification ASA III and more
- A positive intradermal test for sensitivity to a local anaesthetic.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site, 1 recruiting
- Recruiting
Rivne Oblast State Hospital
Rivne, Rivne Oblast, 33000
Maksym Barsa, +380952074098, maksymbarsa@gmail.com
About this study
Improving the anesthesiology management for surgical correction of spinal deformations with introducing the diagnostic methods and treatment strategy of acute pain, preventing the evolution of chronic pain. Development and implementation in clinical practice perioperative intensive care protocols for surgical correction of spinal deformities.
Read the detailed description
The study will involve patients for whom are indicated a surgical correction of spinal deformations.
The control group will include patients who will undergo surgery under general anesthesia. The study group will include patients who will undergo surgery under general anesthesia using a bilateral bi-level Erector spine plane block.
Stages of the study: preoperative period, onset of anesthesia (induction of anesthesia), maintenance of anesthesia, end of anesthesia, 6th and 12th hours after surgery, 1st, 3rd, 5th day after surgery.
All patients will be given the same preparation for surgery: 5-7 days before the procedure - erythropoietin (50-75 IU / kg) subcutaneously once; iron 100 mg iv daily; thiamine hydrochloride (50 mg), pyridoxine hydrochloride (50 mg), cyanocobalamin (0.5 mg) and ascorbic acid (500 mg) orally, daily. The condition of the cardiovascular and respiratory systems will be assessed by auscultation and percussion of the heart and lungs, the results of electrocardiography, echocardiography, spirometry will by also estimate, vascular Doppler of the lower extremities and neck will by also performed.
Blood tests will be taken before and after surgery (haemoglobin, erythrocytes, leukocytes, colour index, haematocrit, leukocyte formula, erythrocyte sedimentation rate, blood glucose, coagulogram, electrolytes, creatinine, urea, albumin, bilirubin, transaminases, cortisol, testosterone, c-reactive protein).
Patients will be given recommendations on proper nutrition before surgery (solid food is allowed 6 hours before surgery and 150 ml of sweet clear liquid 2 hours before surgery), hospitalization will take place on the day of surgery.
All patients will have two peripheral veins cannulated and a urethral catheter will be installed before surgery. In patients with scoliotic spinal deformity, a central venous catheter will be inserted into the right jugular vein under ultrasound guidance prior to surgery. Antibiotic prophylaxis will be performed two hours before the skin incision. Mechanical bowel preparation and premedication with sedatives will not be performed.
All patients in the operating room will receive paracetamol, dexketoprofen, ondansetron, diphenhydramine, dexamethasone, atropine, tranexamic acid. For induction of anesthesia - propofol, thiopental, fentanyl, atracurium besylate, suxamethonium iodide. After preoxygenation - intubation of the trachea in an improved position and further rotation on the abdomen with specific placement of the patient to prevent compression of the abdominal cavity. In patients with scoliotic spinal deformity in the abdominal position will be used a lung recruitment manoeuvre (gradual increasing in positive end-expiratory pressure and inspiratory pressure with assessment of tidal volume and lung pliability), and subsequent protective ventilation and supporting Driving Pressure 12-14 cm H2O.
The operation will be performed under general inhalation anesthesia with sevoflurane and dexmedetomidine infusion. In patients undergoing neuromonitoring, relaxants will be administered only for tracheal intubation.
Intraoperatively, all patients will be monitored for electrocardiography, respiratory rate, body temperature, systolic, diastolic and mean blood pressure, heart rate, pulse oximetry.
During the operation, an assessment of blood loss and subsequent balanced infusion therapy will be performed. The volume and rate of urination will be assessed. A constant infusion of tranexamic acid will be established. Controlled arterial hypotension with mean blood pressure of at least 60 mm Hg will be maintained. To protect the spinal cord and its roots from ischemic injury during the derotation maneuver, mean blood pressure will be maintained at normal or elevated levels.
Correction of blood loss will be carried out with balanced solutions of crystalloids. Blood transfusion will be started at Hb less than 90 g / l. Patients will be warmed by the Warm Touch heating system. All patients will be extubated in the early postoperative period.
For the purpose of analgesia in the postoperative period, patients of both groups will receive paracetamol and dexketoprofen, thromboprophylaxis will be performed depending on the risk of thromboembolic complications.
In the study group, after intubation of the trachea and rotation on the abdomen before the skin incision will be performed bilateral bi-level Erector spine plane block. Before surgery, the level of screw placement will be discussed with the surgeon, and the blockade will be performed at two levels of the spine bilaterally as close as possible to the screw placement site. For blockade a solution for prolonged blockade of peripheral nerve plexuses with bupivacaine 0.375%, dexamethasone 0.02% and epinephrine 0.00018% will be used (Patent №133643 Ukraine 'Solution for prolonged blockade of peripheral nerve plexuses' inventor and owner Barsa Maksym № u201900272, declared 10.01.2019, valid from 10.04.2019, Bulletin № 7).
The total amount of solution administered is 40 ml (10 ml per injection). The erector spine muscle and the transverse process of the spine will be identified using a linear ultrasound probe at the required level of the spine 3cm laterally from the spinous process. Then, using an echogenic needle under ultrasound control in a space between the Erector spine muscle and the transverse process bilaterally on two levels of the spine a local anaesthetic with adjuvants will be injected (Patent №140510 Ukraine 'Method of anaesthesiologic securement for surgical correction of scoliosis spinal deformity' inventor and owner Barsa Marsym № u201911515, claimed 28.11.2019, valid from 25.02.2020, Bulletin № 4).
- Conditions
- Scoliosis, Spinal Deformity, Acute Pain, Chronic Pain, Postoperative Pain, Anesthesia
- Being tested
- Bilateral bi-level Erector spine plane block, General anaesthesia
- Keywords
- Erector spinae plane block, Regional anesthesia, Scoliosis, Spinal Deformity, Multimodal analgesia
- Medical subject headings
- Scoliosis, Acute Pain, Chronic Pain, Pain, Postoperative, Hyperalgesia, Intraoperative Complications, Blood Loss, Surgical, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral bi-level Erector spine plane blockProcedure or surgery
After intubation of the trachea and rotation on the abdomen before the skin incision will be performed bilateral bi-level Erector spine plane block. Before surgery, the level of screw placement will be discussed with the surgeon, and the blockade will be performed at two levels of the spine bilaterally as close as possible to the screw placement site. For blockade a solution for prolonged blockade of peripheral nerve plexuses with bupivacaine 0.375%, dexamethasone 0.02% and epinephrine 0.00018% will be used.
General anaesthesiaProcedure or surgery
The control group - will include patients who will undergo surgery under general anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| The Control Group | Active comparator | The control group will include patients who will undergo surgery under general anesthesia. Receives: Procedure: General anaesthesia |
| The Study Group | Experimental | The study group will include patients who will undergo surgery under general anesthesia using a bilateral bi-level Erector spine plane block. Receives: Procedure: Bilateral bi-level Erector spine plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Numeric Pain Rating Scale
The 11-point numeric scale ranges from '0' representing one pain extreme - "no pain"; to '10' representing the other pain extreme - "pain as bad as you can imagine" or "worst pain imaginable". Will be measured in rest and in the movement.
Measured: On the 1st, 2rd and 3th day after surgery
Duration of hospitalization
Measured: Through study completion, an average of 1 year
Time of weaning the patient from mechanical ventilation
Measured: From a few minutes to an hour
Secondary outcomes (17)
The amount of opioid administered during surgery and in the postoperative period
Measured: Through study completion, an average of 1 year
Mechanical pain threshold and sensitivity
A set of 20 calibrated von Frey monofilaments will be used to determine the mechanical pain threshold. We will make pressure by the monofilament on the skin with increasing force from 0.008 grams to 180 grams. The patient will be asked to close his eyes and we will press the monofilament to the skin surface at an angle of 90 ° until the monofilament bends for 1-1.5 seconds. Monofilaments will be used in ascending order. An interval of 10 s will be maintained between studies. Mechanical pain threshold will be defined as the lowest force of pressure that will be perceived by the patient as pain. Determination of the mechanical pain threshold will be performed in two areas - on the palmar surface of the forearm and on the scapular lines.
Measured: Baseline, on the 1st, 3rd and 5th day after surgery
Overall satisfaction with analgesia will be assessed on a 5-point Likert scale
A type of psychometric response scale in which responders specify their level of satisfaction with analgesia in five points: 5 - Excellent, 4 - Good, 3 - More or less good (pretty good), 2 - Bad, 1 - Very bad.
Measured: Through study completion, an average of 1 year
Level of postoperative sedation will be assessed with Richmond Agitation-Sedation Scale
A medical scale used to measure the agitation or sedation level of a person. (+4) - Combative (Overtly combative or violent; immediate danger to staff); (+3) - Very agitated (Pulls on or removes tubes or catheters or has aggressive behavior toward staff); (+2) - Agitated (Frequent nonpurposeful movement or patient-ventilator dyssynchrony); (+1) - Restless (Anxious or apprehensive but movements not aggressive or vigorous); (0) - Alert and calm (Spontaneously pays attention to caregiver); (-1) - Drowsy (Not fully alert, but has sustained, more than 10 seconds, awakening, with eye contact, to voice); (-2) - Light sedation (Briefly, less than 10 seconds, awakens with eye contact to voice); (-3) - Moderate sedation (Any movement, but no eye contact, to voice); (-4) - Deep sedation (No response to voice, but any movement to physical stimulation); (-5) - Unarousable (No response to voice or physical stimulation)
Measured: On the 1st day after surgery
In the group of patients which will undergo general anaesthesia with Erector spine plane block, anaesthetised dermatomes will be counted along the paravertebral, scapular, anterior, middle and posterior axillary, midclavicular and parasternal lines
It will be measured by response to von Frey hair stimulation
Measured: Baseline, 1st day after surgery
Blood glucose level
Measured: Baseline, 1st and 5th day after surgery
Blood testosterone level
Measured: Baseline, 1st and 5th day after surgery
Blood cortisol level
Measured: Baseline, 1st and 5th day after surgery
Blood C-reactive protein level
Measured: Baseline, 1st and 5th day after surgery
Erythrocyte sedimentation rate
Measured: Baseline, 1st and 5th day after surgery
Mean blood pressure
Measured: Baseline, during and 1st hour after surgery
Heart rate
Measured: Baseline, during and 1st hour after surgery
Nociceptive respond index
The nociceptive response index was calculated every 15 minutes during surgery, using the nociceptive response index formula, which includes the intra-operative haemodynamic variables HR, SBP and perfusion index
Measured: Every 15 minutes during surgery
Blood loss
By weighing the wipes before and after use, measuring the amount of blood in the suction flask.
Measured: Baseline, during and 1st hour after surgery
Urination
Measured: Baseline, during and 1st hour after surgery
Infusion therapy
Measured: Baseline, during and 1st hour after surgery
Episodes of nausea, belching, vomiting and constipation
Measured: Five days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start16 Dec 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lviv National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maksym Barsa, Lviv National Medical University
- Investigators
- Maksym Barsa, Principal investigator, Rivne Region Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697498
- Sponsor's protocol ID
- LNMY-FPGE- ANESTHESIOLOGY-BBES
- Acronym
- BBESPB
- Status last verified
- Oct 2023
- First submitted
- 29 Dec 2020
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barsa M. Comparison of the impact of the method of anesthesia on intraoperative nociceptive response during spine surgeries: Prospective randomized control trial. J Opioid Manag. 2026 May-Jun;22(3):259-268. doi: 10.5055/jom.0943.
PubMed 42615297
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations
- ClinicalTrials.gov ID
- NCT04697498
- Acronym / sponsor ID
- BBESPB / LNMY-FPGE- ANESTHESIOLOGY-BBES
- Conditions
- Scoliosis, Spinal Deformity, Acute Pain, Chronic Pain, Postoperative Pain, Anesthesia
- Keywords
- Erector spinae plane block, Regional anesthesia, Scoliosis, Spinal Deformity, Multimodal analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lviv National Medical UniversityUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 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.
Improving the anesthesiology management for surgical correction of spinal deformations with introducing the diagnostic methods and treatment strategy of acute pain, preventing the evolution of chronic pain. Development and implementation in clinical practice perioperative intensive care protocols for surgical correction of spinal deformities.
Detailed description
The study will involve patients for whom are indicated a surgical correction of spinal deformations.
The control group will include patients who will undergo surgery under general anesthesia. The study group will include patients who will undergo surgery under general anesthesia using a bilateral bi-level Erector spine plane block.
Stages of the study: preoperative period, onset of anesthesia (induction of anesthesia), maintenance of anesthesia, end of anesthesia, 6th and 12th hours after surgery, 1st, 3rd, 5th day after surgery.
All patients will be given the same preparation for surgery: 5-7 days before the procedure - erythropoietin (50-75 IU / kg) subcutaneously once; iron 100 mg iv daily; thiamine hydrochloride (50 mg), pyridoxine hydrochloride (50 mg), cyanocobalamin (0.5 mg) and ascorbic acid (500 mg) orally, daily. The condition of the cardiovascular and respiratory systems will be assessed by auscultation and percussion of the heart and lungs, the results of electrocardiography, echocardiography, spirometry will by also estimate, vascular Doppler of the lower extremities and neck will by also performed.
Blood tests will be taken before and after surgery (haemoglobin, erythrocytes, leukocytes, colour index, haematocrit, leukocyte formula, erythrocyte sedimentation rate, blood glucose, coagulogram, electrolytes, creatinine, urea, albumin, bilirubin, transaminases, cortisol, testosterone, c-reactive protein).
Patients will be given recommendations on proper nutrition before surgery (solid food is allowed 6 hours before surgery and 150 ml of sweet clear liquid 2 hours before surgery), hospitalization will take place on the day of surgery.
All patients will have two peripheral veins cannulated and a urethral catheter will be installed before surgery. In patients with scoliotic spinal deformity, a central venous catheter will be inserted into the right jugular vein under ultrasound guidance prior to surgery. Antibiotic prophylaxis will be performed two hours before the skin incision. Mechanical bowel preparation and premedication with sedatives will not be performed.
All patients in the operating room will receive paracetamol, dexketoprofen, ondansetron, diphenhydramine, dexamethasone, atropine, tranexamic acid. For induction of anesthesia - propofol, thiopental, fentanyl, atracurium besylate, suxamethonium iodide. After preoxygenation - intubation of the trachea in an improved position and further rotation on the abdomen with specific placement of the patient to prevent compression of the abdominal cavity. In patients with scoliotic spinal deformity in the abdominal position will be used a lung recruitment manoeuvre (gradual increasing in positive end-expiratory pressure and inspiratory pressure with assessment of tidal volume and lung pliability), and subsequent protective ventilation and supporting Driving Pressure 12-14 cm H2O.
The operation will be performed under general inhalation anesthesia with sevoflurane and dexmedetomidine infusion. In patients undergoing neuromonitoring, relaxants will be administered only for tracheal intubation.
Intraoperatively, all patients will be monitored for electrocardiography, respiratory rate, body temperature, systolic, diastolic and mean blood pressure, heart rate, pulse oximetry.
During the operation, an assessment of blood loss and subsequent balanced infusion therapy will be performed. The volume and rate of urination will be assessed. A constant infusion of tranexamic acid will be established. Controlled arterial hypotension with mean blood pressure of at least 60 mm Hg will be maintained. To protect the spinal cord and its roots from ischemic injury during the derotation maneuver, mean blood pressure will be maintained at normal or elevated levels.
Correction of blood loss will be carried out with balanced solutions of crystalloids. Blood transfusion will be started at Hb less than 90 g / l. Patients will be warmed by the Warm Touch heating system. All patients will be extubated in the early postoperative period.
For the purpose of analgesia in the postoperative period, patients of both groups will receive paracetamol and dexketoprofen, thromboprophylaxis will be performed depending on the risk of thromboembolic complications.
In the study group, after intubation of the trachea and rotation on the abdomen before the skin incision will be performed bilateral bi-level Erector spine plane block. Before surgery, the level of screw placement will be discussed with the surgeon, and the blockade will be performed at two levels of the spine bilaterally as close as possible to the screw placement site. For blockade a solution for prolonged blockade of peripheral nerve plexuses with bupivacaine 0.375%, dexamethasone 0.02% and epinephrine 0.00018% will be used (Patent №133643 Ukraine 'Solution for prolonged blockade of peripheral nerve plexuses' inventor and owner Barsa Maksym № u201900272, declared 10.01.2019, valid from 10.04.2019, Bulletin № 7).
The total amount of solution administered is 40 ml (10 ml per injection). The erector spine muscle and the transverse process of the spine will be identified using a linear ultrasound probe at the required level of the spine 3cm laterally from the spinous process. Then, using an echogenic needle under ultrasound control in a space between the Erector spine muscle and the transverse process bilaterally on two levels of the spine a local anaesthetic with adjuvants will be injected (Patent №140510 Ukraine 'Method of anaesthesiologic securement for surgical correction of scoliosis spinal deformity' inventor and owner Barsa Marsym № u201911515, claimed 28.11.2019, valid from 25.02.2020, Bulletin № 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Control Group | Active comparator | Procedure: General anaesthesiaThe control group will include patients who will undergo surgery under general anesthesia. |
| The Study Group | Experimental | Procedure: Bilateral bi-level Erector spine plane blockThe study group will include patients who will undergo surgery under general anesthesia using a bilateral bi-level Erector spine plane block. |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent of the patient or his legal representatives to participate the study.
- Spinal deformity that requires surgical correction.
- No known allergies to local anaesthetics.
- Negative intradermal test for sensitivity to local anaesthetics.
Key exclusion criteria (5 listed)
- Refusal of the patient or his legal representatives to participate the study
- Diabetes mellitus, known allergy to local anaesthetics
- Acute spinal cord injury
- Physical status according to classification ASA III and more
- A positive intradermal test for sensitivity to a local anaesthetic.
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 |
|---|---|---|
| Bilateral bi-level Erector spine plane blockAfter intubation of the trachea and rotation on the abdomen before the skin incision will be performed bilateral bi-level Erector spine plane block. Before surgery, the level of screw placement will be discussed with the surgeon, and the blockade will be performed at two levels of the spine bilaterally as close as possible to the screw placement site. For blockade a solution for prolonged blockade of peripheral nerve plexuses with bupivacaine 0.375%, dexamethasone 0.02% and epinephrine 0.00018% will be used. | Procedure or surgery | The Study Group |
| General anaesthesiaThe control group - will include patients who will undergo surgery under general anaesthesia | Procedure or surgery | The Control Group |
Primary outcome
Change in The Numeric Pain Rating Scale
Time frame: On the 1st, 2rd and 3th day after surgery
The 11-point numeric scale ranges from '0' representing one pain extreme - "no pain"; to '10' representing the other pain extreme - "pain as bad as you can imagine" or "worst pain imaginable". Will be measured in rest and in the movement.
Duration of hospitalization
Time frame: Through study completion, an average of 1 year
Time of weaning the patient from mechanical ventilation
Time frame: From a few minutes to an hour
17 secondary outcomes
The amount of opioid administered during surgery and in the postoperative period
Time frame: Through study completion, an average of 1 year
Mechanical pain threshold and sensitivity
Time frame: Baseline, on the 1st, 3rd and 5th day after surgery
Overall satisfaction with analgesia will be assessed on a 5-point Likert scale
Time frame: Through study completion, an average of 1 year
Level of postoperative sedation will be assessed with Richmond Agitation-Sedation Scale
Time frame: On the 1st day after surgery
In the group of patients which will undergo general anaesthesia with Erector spine plane block, anaesthetised dermatomes will be counted along the paravertebral, scapular, anterior, middle and posterior axillary, midclavicular and parasternal lines
Time frame: Baseline, 1st day after surgery
Blood glucose level
Time frame: Baseline, 1st and 5th day after surgery
Blood testosterone level
Time frame: Baseline, 1st and 5th day after surgery
Blood cortisol level
Time frame: Baseline, 1st and 5th day after surgery
Blood C-reactive protein level
Time frame: Baseline, 1st and 5th day after surgery
Erythrocyte sedimentation rate
Time frame: Baseline, 1st and 5th day after surgery
Mean blood pressure
Time frame: Baseline, during and 1st hour after surgery
Heart rate
Time frame: Baseline, during and 1st hour after surgery
Nociceptive respond index
Time frame: Every 15 minutes during surgery
Blood loss
Time frame: Baseline, during and 1st hour after surgery
Urination
Time frame: Baseline, during and 1st hour after surgery
Infusion therapy
Time frame: Baseline, during and 1st hour after surgery
Episodes of nausea, belching, vomiting and constipation
Time frame: Five days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 42615297Barsa M. Comparison of the impact of the method of anesthesia on intraoperative nociceptive response during spine surgeries: Prospective randomized control trial. J Opioid Manag. 2026 May-Jun;22(3):259-268. doi: 10.5055/jom.0943.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Maksym Barsa principal investigator
Rivne Region Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral bi-level Erector spine plane block and General anaesthesia in people with Scoliosis and Spinal Deformity, run by Lviv National Medical University at 1 site in Ukraine.
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: status not confirmed, as of the sponsor's last update on 5 Oct 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 Ukraine. 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 Maksym Barsa (+380952074098, maksymbarsa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Numeric Pain Rating Scale (time frame: On the 1st, 2rd and 3th day after surgery). The study lists 3 primary outcomes in all. 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 NCT04697498, which also lists 1 linked publication.
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 5 Oct 2023.