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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 25
Healthy Volunteers: f
View:
• Patients over the age of 12 with normal cognition, who are scheduled to undergo surgery to correct scoliosis and treatment with IV PCA independently for pain relief after surgery; The patients' parents/guardian (in the case of a minor) or the patient himself (in the case of an adult) signed an informed consent form for participation in the study; Patients should be able to operate the PCA device independently
Locations
Other Locations
Israel
Shamir (Asaf Harofe) Medical Center
RECRUITING
Be’er Ya‘aqov
Contact Information
Primary
Sara Bar Yehuda, PhD
sarabar1@shamir.gov.il
972528981004
Backup
Zoya Haitov Ben Zikri, MD
ZoyaC@shamir.gov.il
972537346186
Time Frame
Start Date:2024-09-01
Estimated Completion Date:2026-09-30
Participants
Target number of participants:105
Treatments
No_intervention: Control
This group will serve as a control - the patients will receive general anesthesia according to the standard protocol for general anesthesia in this study. Upon the end of the surgery, patients will begin receiving analgesics and anti-nausea treatment according to the standard protocol in this study.
Active_comparator: Erector spinae plane block
Patients will receive general anesthesia according to the standard protocol for general anesthesia in this study. After induction for anesthesia, before the start of the surgery, the anesthesiologist will perform an ultrasound guided ESP block, according to the ultrasound guided erector spinae plane block protocol
Active_comparator: Lidocaine
Patients will receive general anesthesia according to the standard general anesthesia protocol for this study. In addition, after induction of anesthesia, patients will begin receiving an intravenous infusion of lidocaine at a dose of 0.5 mg per kg per hour, and will continue to receive the infusion after surgery for a total of 24 hours.