Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in The Numeric Pain Rating Scale
Study Overview
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.
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
The Control Group
The control group will include patients who will undergo surgery under general anesthesia.
Intervention: General anaesthesia (Procedure)
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.
Intervention: Bilateral bi-level Erector spine plane block (Procedure)
Outcomes
Primary Outcomes
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.
Duration of hospitalization
Time Frame: Through study completion, an average of 1 year
Time of weaning the patient from mechanical ventilation
Time Frame: From a few minutes to an hour
Secondary Outcomes
- Infusion therapy(Baseline, during and 1st hour 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)
- Erythrocyte sedimentation rate(Baseline, 1st and 5th day after surgery)
- Mean blood pressure(Baseline, during and 1st hour after surgery)
- Nociceptive respond index(Every 15 minutes during surgery)
- 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)
- Blood glucose level(Baseline, 1st and 5th day after surgery)
- Blood C-reactive protein level(Baseline, 1st and 5th day after surgery)
- Heart rate(Baseline, during and 1st hour 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)
- Blood testosterone level(Baseline, 1st and 5th day after surgery)
- Episodes of nausea, belching, vomiting and constipation(Five days after surgery)
- Blood cortisol level(Baseline, 1st and 5th day after surgery)
- Blood loss(Baseline, during and 1st hour after surgery)
- Urination(Baseline, during and 1st hour after surgery)
Investigators
Maksym Barsa
Principal Investigator
Lviv National Medical University