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

NCT04697498 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-10-05

No results posted yet for this study

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

Interventions

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.

PROCEDURE

General anaesthesia

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

Sponsors & Collaborators

  • Lviv National Medical University

    lead OTHER

Principal Investigators

  • Maksym Barsa · Rivne Region Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04697498 on ClinicalTrials.gov