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

• ClinicalTrials.gov Identifier: NCT04697498
• Recruitment Status: Recruiting
• First Posted: January 6, 2021
• Last Update Posted: January 8, 2021
• Sponsor: Lviv National Medical University
• Information provided by (Responsible Party): Maksym Barsa, Lviv National Medical University

Study Description

Brief 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. Development and implementation in clinical practice perioperative intensive care protocols for surgical correction of spinal deformities.

Condition or disease	Intervention/treatment	Phase
Scoliosis; Spinal Deformity; Acute Pain; Chronic Pain; Postoperative Pain; Anesthesia; Regional Anesthesia Morbidity; Anesthesia, Local; Anesthesia Complication; Hyperalgesia; Intraoperative Complications; Intraoperative Hypotension; Intraoperative Blood Loss; Intraoperative Bleeding; Intraoperative Neurological Injury; Intraoperative Injury; Coagulation Disorder; Postoperative Nausea and Vomiting; Postoperative Cognitive Dysfunction; Neuropathic Pain; Nutrient Deficiency; Nutrition Disorders; Ventilator-Induced Lung Injury	Procedure: Bilateral bi-level Erector spine plane block; Procedure: General anaesthesia	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations
• Actual Study Start Date: December 16, 2020
• Estimated Primary Completion Date: December 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Duration of hospitalization [ Time Frame: Through study completion, an average of 1 year ]
3. Time of weaning the patient from mechanical ventilation [ Time Frame: From a few minutes to an hour ]

Secondary Outcome Measures :

1. The amount of opioid administered during surgery and in the postoperative period [ Time Frame: Through study completion, an average of 1 year ]
2. Mechanical pain threshold and sensitivity [ Time Frame: Baseline, on the 1st, 3rd and 5th day after surgery ]
   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.
3. Overall satisfaction with analgesia will be assessed on a 5-point Likert scale [ Time Frame: Through study completion, an average of 1 year ]
   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.
4. Level of postoperative sedation will be assessed with Richmond Agitation-Sedation Scale [ Time Frame: On the 1st day after surgery ]
   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)
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 [ Time Frame: Baseline, 1st day after surgery ]
   It will be measured by response to von Frey hair stimulation
6. Blood glucose level [ Time Frame: Baseline, 1st and 5th day after surgery ]
7. Blood testosterone level [ Time Frame: Baseline, 1st and 5th day after surgery ]
8. Blood cortisol level [ Time Frame: Baseline, 1st and 5th day after surgery ]
9. Blood C-reactive protein level [ Time Frame: Baseline, 1st and 5th day after surgery ]
10. Erythrocyte sedimentation rate [ Time Frame: Baseline, 1st and 5th day after surgery ]
11. Mean blood pressure [ Time Frame: Baseline, during and 1st hour after surgery ]
12. Heart rate [ Time Frame: Baseline, during and 1st hour after surgery ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Maksym Barsa; +380952074098; maksymbarsa@gmail.com

Locations

Ukraine

Rivne Oblast State Hospital; Recruiting

Rivne, Rivne Region, Ukraine, 33000

Contact: Maksym Barsa +380952074098 maksymbarsa@gmail.com

Sponsors and Collaborators

Lviv National Medical University

Investigators

• Principal Investigator: Maksym Barsa; Rivne Region Hospital

More Information

Additional Information:

Related Info 

• Responsible Party: Maksym Barsa, Principal Investigator, Lviv National Medical University
• ClinicalTrials.gov Identifier: NCT04697498
• Other Study ID Numbers: LNMY-FPGE- ANESTHESIOLOGY-BBES
• First Posted: January 6, 2021
• Last Update Posted: January 8, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maksym Barsa, Lviv National Medical University:

Erector spinae plane block; Regional anesthesia; Scoliosis; Spinal Deformity; Multimodal analgesia

Additional relevant MeSH terms:

Scoliosis; Lung Injury; Ventilator-Induced Lung Injury; Neuralgia; Hyperalgesia; Trauma, Nervous System; Hypotension; Hemostatic Disorders; Blood Coagulation Disorders; Congenital Abnormalities; Nutrition Disorders; Disease; Chronic Pain; Vomiting; Acute Pain; Postoperative Nausea and Vomiting; Postoperative Cognitive Complications; Intraoperative Complications; Blood Loss, Surgical; Wounds and Injuries; Cognitive Dysfunction; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Nausea; Signs and Symptoms, Digestive; Vascular Diseases; Cardiovascular Diseases; Peripheral Nervous System Diseases