Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451562
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-21
Brief Title:
Effect of Regional Anesthesia or Intravenous Infusion of Lidocaine on Morphine Use After Scoliosis Repair Surgery
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
A Controlled Study to Compare the Effect of Regional Anesthesia by an Erector Spine Plane Block and Intravenous Infusion of Lidocaine on the Rate of Intravenous Morphine Use After Scoliosis Repair Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The goal of the surgical correction of scoliosis is to prevent progression of the curve or progression of restrictive lung disease After scoliosis surgery patients experience severe pain The standard treatment for pain relief after scoliosis surgery is the administration of opiates However treatment with these substances involves side effects such as respiratory depression nausea and vomiting inhibition of bowel activity and itching To lower the dose of opiates different types of painkillers and other techniques can be added
The purpose of the study is to compare the effect of instillation of lidocaine which is an analgesic and anti-inflammatory or regional anesthesia using Erector spinae plane on the dose of morphine consumption the intensity of pain the side effects and the quality of recovery during the first 48 hours after surgery to repair scoliosis
The purpose of the study is to compare the effect of instillation of lidocaine which is an analgesic and anti-inflammatory or regional anesthesia using Erector spinae plane on the dose of morphine consumption the intensity of pain the side effects and the quality of recovery during the first 48 hours after surgery to repair scoliosis
Detailed Description:
The goal of the surgical correction of scoliosis is to prevent progression of the curve or progression of restrictive lung disease After scoliosis surgery patients experience severe pain The standard treatment for pain relief after scoliosis surgery is the administration of opiates The opiate that is usually used after scoliosis repair surgery to correct scoliosis is morphine It is given independently by the patients using the patient-controlled analgesia device However treatment with these substances involves side effects such as respiratory depression nausea and vomiting inhibition of bowel activity and itching To lower the dose of opiates different types of painkillers and other techniques can be added
The purpose of the study is to compare the effect of instillation of lidocaine which is an analgesic and anti-inflammatory or regional anesthesia using Erector spinae plane on the dose of morphine consumption the intensity of pain the side effects and the quality of recovery during the first 48 hours after surgery to repair scoliosis
Patients will be randomized to one of 3 groups The patients do not know which group they belong to
Group C - control - the patients will receive general anesthesia according to the standard protocol for general anesthesia in this study
Group B - ESP block - patients will receive general anesthesia according to the standard protocol for general anesthesia in this study And then the anesthesiologist will perform an ultrasound-guided ESP block
Group L - Lidocaine - Patients will receive general anesthesia according to the standard protocol for general anesthesia for this study In addition after induction of anesthesia patients will begin receiving an intravenous infusion of lidocaine and will continue to receive the infusion after surgery for a total of 24 hours
The patients will be connected to the PCA device by the anesthetists before leaving for recovery unit The patients will receive an explanation before and after the operation to press the PCA bolus only if there is strong bursting pain 48 hours after the surgery the PCA will be stopped and patients will receive other pain relievers as needed
Patient report data on the level of pain and nausea will be collected 1 6 12 24 and 48 hours after the end of the surgery Data will also be collected on the maximum dose of morphine that the patient received from the PCA pump 24 and 48 hours after the end of the operation the time of the first bowel movement and the time of the first walk as well as demographic data of the patients The QOR-15 questionnaire to check the quality of recovery will be filled out by the patients 72 hours after the end of the surgery
The purpose of the study is to compare the effect of instillation of lidocaine which is an analgesic and anti-inflammatory or regional anesthesia using Erector spinae plane on the dose of morphine consumption the intensity of pain the side effects and the quality of recovery during the first 48 hours after surgery to repair scoliosis
Patients will be randomized to one of 3 groups The patients do not know which group they belong to
Group C - control - the patients will receive general anesthesia according to the standard protocol for general anesthesia in this study
Group B - ESP block - patients will receive general anesthesia according to the standard protocol for general anesthesia in this study And then the anesthesiologist will perform an ultrasound-guided ESP block
Group L - Lidocaine - Patients will receive general anesthesia according to the standard protocol for general anesthesia for this study In addition after induction of anesthesia patients will begin receiving an intravenous infusion of lidocaine and will continue to receive the infusion after surgery for a total of 24 hours
The patients will be connected to the PCA device by the anesthetists before leaving for recovery unit The patients will receive an explanation before and after the operation to press the PCA bolus only if there is strong bursting pain 48 hours after the surgery the PCA will be stopped and patients will receive other pain relievers as needed
Patient report data on the level of pain and nausea will be collected 1 6 12 24 and 48 hours after the end of the surgery Data will also be collected on the maximum dose of morphine that the patient received from the PCA pump 24 and 48 hours after the end of the operation the time of the first bowel movement and the time of the first walk as well as demographic data of the patients The QOR-15 questionnaire to check the quality of recovery will be filled out by the patients 72 hours after the end of the surgery
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