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

NCT04697498 | Unknown

• 1 other identifier: LNMY-FPGE- ANESTHESIOLOGY-BBES
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• 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

  Baseline, on the 1st, 3rd and 5th day after surgery

• Overall satisfaction with analgesia will be assessed on a 5-point Likert scale

  Through study completion, an average of 1 year

• Level of postoperative sedation will be assessed with Richmond Agitation-Sedation Scale

  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

  Baseline, 1st day after surgery

Study Arms (2)

The Control Group

ACTIVE COMPARATOR

The control group will include patients who will undergo surgery under general anesthesia.

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.

Procedure: Bilateral bi-level Erector spine plane block

Interventions

Bilateral bi-level Erector spine plane block PROCEDURE

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.

The Study Group

General anaesthesia PROCEDURE

The control group - will include patients who will undergo surgery under general anaesthesia

The Control Group

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lviv National Medical University: lead

Study Sites (1)

Rivne Oblast State Hospital

Rivne, Rivne Oblast, 33000, Ukraine

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Scoliosis; Acute Pain; Chronic Pain; Pain, Postoperative; Hyperalgesia; Intraoperative Complications; Blood Loss, Surgical; Hemostatic Disorders; Postoperative Nausea and Vomiting; Postoperative Cognitive Complications; Neuralgia; Nutrition Disorders; Ventilator-Induced Lung Injury

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases; Hemorrhage; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Nausea; Signs and Symptoms, Digestive; Vomiting; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nutritional and Metabolic Diseases; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Maksym Barsa

  Rivne Region Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maksym Barsa

CONTACT

+380952074098; maksymbarsa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 6, 2021
• Study Start: December 16, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

UA (1)