Chronic Pain Clinical Trial
— BBESPBOfficial title:
Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Ukraine | Rivne Oblast State Hospital | Rivne | Rivne Region |
Lead Sponsor | Collaborator |
---|---|
Lviv National Medical University |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Duration of hospitalization | Through study completion, an average of 1 year | ||
Primary | Time of weaning the patient from mechanical ventilation | From a few minutes to an hour | ||
Secondary | The amount of opioid administered during surgery and in the postoperative period | Through study completion, an average of 1 year | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Blood glucose level | Baseline, 1st and 5th day after surgery | ||
Secondary | Blood testosterone level | Baseline, 1st and 5th day after surgery | ||
Secondary | Blood cortisol level | Baseline, 1st and 5th day after surgery | ||
Secondary | Blood C-reactive protein level | Baseline, 1st and 5th day after surgery | ||
Secondary | Erythrocyte sedimentation rate | Baseline, 1st and 5th day after surgery | ||
Secondary | Mean blood pressure | Baseline, during and 1st hour after surgery | ||
Secondary | Heart rate | Baseline, during and 1st hour after surgery | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | Urination | Baseline, during and 1st hour after surgery | ||
Secondary | Infusion therapy | Baseline, during and 1st hour after surgery | ||
Secondary | Episodes of nausea, belching, vomiting and constipation | Five days after surgery |
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