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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Rivne Oblast State Hospital

    Rivne, Rivne Oblast, 33000

    Maksym Barsa, +380952074098, maksymbarsa@gmail.com

    Recruiting

Other trials in Ukraine

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).

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 groups in NCT04697498
Study groupRoleWhat they receive
The Control GroupActive comparatorThe control group will include patients who will undergo surgery under general anesthesia.
Receives: Procedure: General anaesthesia
The Study GroupExperimentalThe 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.

  1. 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

  2. Duration of hospitalization

    Measured: Through study completion, an average of 1 year

  3. Time of weaning the patient from mechanical ventilation

    Measured: From a few minutes to an hour

Secondary outcomes (17)
  1. The amount of opioid administered during surgery and in the postoperative period

    Measured: Through study completion, an average of 1 year

  2. 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

  3. 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

  4. 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

  5. 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

  6. Blood glucose level

    Measured: Baseline, 1st and 5th day after surgery

  7. Blood testosterone level

    Measured: Baseline, 1st and 5th day after surgery

  8. Blood cortisol level

    Measured: Baseline, 1st and 5th day after surgery

  9. Blood C-reactive protein level

    Measured: Baseline, 1st and 5th day after surgery

  10. Erythrocyte sedimentation rate

    Measured: Baseline, 1st and 5th day after surgery

  11. Mean blood pressure

    Measured: Baseline, during and 1st hour after surgery

  12. Heart rate

    Measured: Baseline, during and 1st hour after surgery

  13. 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

  14. 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

  15. Urination

    Measured: Baseline, during and 1st hour after surgery

  16. Infusion therapy

    Measured: Baseline, during and 1st hour after surgery

  17. 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.

  1. First posted6 Jan 2021
  2. Study start16 Dec 2020
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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

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.

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