Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations (BBESPB)

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition Disorders; Chronic Pain; Postoperative Pain; Anesthesia, Local; Postoperative Cognitive Dysfunction; Scoliosis; Coagulation Disorder; Acute Pain; Neuropathic Pain; Anesthesia; Postoperative Nausea and Vomiting; Ventilator-Induced Lung Injury; Intraoperative Complications; Hyperalgesia; Regional Anesthesia Morbidity; Spinal Deformity; Intraoperative Bleeding; Intraoperative Hypotension; Nutrient Deficiency; Anesthesia Complication; Intraoperative Injury; Intraoperative Blood Loss; Intraoperative Neurological Injury
• Intervention / Treatment: Procedure: General anaesthesia; Procedure: Bilateral bi-level Erector spine plane block

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maksym Barsa; Phone Number: +380952074098; Email: maksymbarsa@gmail.com

Study Locations

• Ukraine
  • Rivne Region
    • Rivne, Rivne Region, Ukraine, 33000
      • Recruiting
      • Rivne Oblast State Hospital
      • Contact: Maksym Barsa; Phone Number: +380952074098; Email: maksymbarsa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Informed consent of the patient or his legal representatives to participate the study.
2. Spinal deformity that requires surgical correction.
3. No known allergies to local anaesthetics.
4. Negative intradermal test for sensitivity to local anaesthetics.

Exclusion Criteria:

1. Refusal of the patient or his legal representatives to participate the study
2. Diabetes mellitus, known allergy to local anaesthetics
3. Acute spinal cord injury
4. Physical status according to classification ASA III and more
5. A positive intradermal test for sensitivity to a local anaesthetic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The Control Group; The control group will include patients who will undergo surgery under general anesthesia.	Procedure: General anaesthesia; The control group - will include patients who will undergo surgery under general anaesthesia
Experimental: The Study Group; The study group will include patients who will undergo surgery under general anesthesia using a bilateral bi-level Erector spine plane block.	Procedure: Bilateral bi-level Erector spine plane block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	On the 1st, 2rd and 3th day after surgery
Duration of hospitalization		Through study completion, an average of 1 year
Time of weaning the patient from mechanical ventilation		From a few minutes to an hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of opioid administered during surgery and in the postoperative period		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.	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.	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)	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	Baseline, 1st day after surgery
Blood glucose level		Baseline, 1st and 5th day after surgery
Blood testosterone level		Baseline, 1st and 5th day after surgery
Blood cortisol level		Baseline, 1st and 5th day after surgery
Blood C-reactive protein level		Baseline, 1st and 5th day after surgery
Erythrocyte sedimentation rate		Baseline, 1st and 5th day after surgery
Mean blood pressure		Baseline, during and 1st hour after surgery
Heart rate		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	Every 15 minutes during surgery
Blood loss	By weighing the wipes before and after use, measuring the amount of blood in the suction flask.	Baseline, during and 1st hour after surgery
Urination		Baseline, during and 1st hour after surgery
Infusion therapy		Baseline, during and 1st hour after surgery
Episodes of nausea, belching, vomiting and constipation		Five days after surgery

Collaborators and Investigators

• Sponsor: Lviv National Medical University
• Investigators: Principal Investigator: Maksym Barsa, Rivne Region Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Scoliosis; Erector spinae plane block; Regional anesthesia; Spinal Deformity; Multimodal analgesia
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Lung Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurocognitive Disorders; Hematologic Diseases; Signs and Symptoms, Digestive; Hemorrhage; Hemorrhagic Disorders; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Cognition Disorders; Spinal Curvatures; Sensation Disorders; Thoracic Injuries; Somatosensory Disorders; Nausea; Hemostatic Disorders; Blood Coagulation Disorders; Vomiting; Chronic Pain; Neuralgia; Wounds and Injuries; Cognitive Dysfunction; Congenital Abnormalities; Postoperative Cognitive Complications; Scoliosis; Acute Pain; Hypotension; Lung Injury; Nutrition Disorders; Postoperative Nausea and Vomiting; Blood Loss, Surgical; Trauma, Nervous System; Intraoperative Complications; Hyperalgesia; Ventilator-Induced Lung Injury; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: LNMY-FPGE- ANESTHESIOLOGY-BBES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No