Effect of Regional Anesthesia or Intravenous Infusion of Lidocaine on Morphine Use After Scoliosis Repair Surgery
- Registration Number
- NCT06451562
- Lead Sponsor
- Assaf-Harofeh Medical Center
- 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 re...
- 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...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 105
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
Patients who do not agree to participate in the study even if their parents signed an informed consent
Patients who are unable to operate the PCA device independently
Patients under treatment with opioids or cannabis for chronic pain for more than a month;
Drug use of any kind;
Alcoholism;
Patients with depression, anxiety or post-trauma;
Moderate-severe insufficiency of one of the systems - respiratory/cardiac/hepatic/renal;
Sensitivity to one of the drugs in the research protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Erector spinae plane block Lidocaine 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 Lidocaine 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.
- Primary Outcome Measures
Name Time Method Morphine consumption 48 hours after surgery Dosage of morphine consumption in milligrams that the patients will consume in by pressing on the PCA device in the first 48 hours after surgery to correct scoliosis
- Secondary Outcome Measures
Name Time Method Quality of recovery 72 hours after surgery The patient will fill the QOR15 questionnaire for Quality of recovery
Pain intensity, 48 hours after surgery. The pain will be monitored at 1, 6, 12, 24 and 48 hours after the surgery. Monitoring the effect of treatments on pain intensity during the first 48 hours after surgery. Using patients' reported NRS scale 0-10 with 0 meaning no pain at all and 10 meaning the worst imaginable pain.
Trial Locations
- Locations (1)
Shamir (Asaf Harofe) Medical Center
🇮🇱Be'er Ya'aqov, Israel