Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697498
Status:
RECRUITING
Last Update Posted:
2023-10-05
First Post:
2020-12-29
Brief Title:
Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations
Sponsor:
Lviv National Medical University
Organization:
Lviv National Medical University
Study Overview
Official Title:
Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BBESPB
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 05 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 0375 dexamethasone 002 and epinephrine 000018 will be used Patent 133643 Ukraine Solution for prolonged blockade of peripheral nerve plexuses inventor and owner Barsa Maksym u201900272 declared 10012019 valid from 10042019 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 28112019 valid from 25022020 Bulletin 4
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 05 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 0375 dexamethasone 002 and epinephrine 000018 will be used Patent 133643 Ukraine Solution for prolonged blockade of peripheral nerve plexuses inventor and owner Barsa Maksym u201900272 declared 10012019 valid from 10042019 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 28112019 valid from 25022020 Bulletin 4
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None