Actively Recruiting
Effect of Regional Anesthesia by Erector Spinae Plane Block and Intravenous Lidocaine Infusion on Morphine Use After Scoliosis Repair Surgery
Led by Assaf-Harofeh Medical Center · Updated on 2024-11-12
105
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates pain management methods following scoliosis repair surgery, aiming to prevent worsening spinal curvature and lung restriction. After surgery, patients often experience severe pain typically treated with morphine via a patient-controlled analgesia (PCA) device. Because morphine and similar opioids can cause side effects like breathing problems, nausea, vomiting, bowel issues, and itching, this study compares two additional pain relief techniques to reduce morphine use and improve recovery quality within 48 hours after surgery. Participants will be randomly assigned to one of three groups. The control group receives standard general anesthesia without additional interventions. The second group receives general anesthesia plus an ultrasound-guided erector spinae plane (ESP) block to provide regional anesthesia. The third group receives general anesthesia plus a continuous intravenous infusion of lidocaine starting after anesthesia induction and continuing for 24 hours. Morphine use is controlled by the PCA device, which patients operate themselves to manage pain. Participants will be monitored for 48 hours post-surgery to measure morphine consumption and pain levels at multiple time points. Researchers will also record side effects such as nausea, time to first bowel movement, and time to first walk. Quality of recovery will be assessed using the QOR-15 questionnaire 72 hours after surgery. Demographic and clinical data will be collected to evaluate safety and effectiveness of the pain management approaches during the study period.
CONDITIONS
Brief Title
Effect of Regional Anesthesia or Intravenous Infusion of Lidocaine on Morphine Use After Scoliosis Repair Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 to 25 years with normal cognition
- Scheduled for scoliosis correction surgery
- Able to independently operate the patient-controlled analgesia (PCA) device
- Signed informed consent by patient or guardian
You will not qualify if you...
- Patients who do not agree to participate despite signed consent
- Unable to operate the PCA device independently
- Using opioids or cannabis for chronic pain for more than one month
- Current drug use of any kind
- History of alcoholism
- Diagnosed with depression, anxiety, or post-trauma
- Moderate to severe respiratory, cardiac, liver, or kidney insufficiency
- Sensitivity to any drugs used in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and 24 hours post-surgery
Participants undergo scoliosis repair surgery with general anesthesia. Depending on the group, participants receive either an ultrasound-guided erector spinae plane block or an intravenous lidocaine infusion during and after surgery to manage pain.
1 surgical procedure and continuous monitoring for 24 hours post-surgery
Duration - 48 to 72 hours after surgery
Participants use a patient-controlled analgesia (PCA) device to manage pain for 48 hours after surgery. Pain intensity, nausea, morphine consumption, bowel movement, walking ability, and recovery quality are monitored.
Assessments at 1, 6, 12, 24, 48, and 72 hours post-surgery
Trial Site Locations
Total: 1 location
1
Shamir (Asaf Harofe) Medical Center
Be’er Ya‘aqov, Israel, 70300
Actively Recruiting
Research Team
S
Sara Bar Yehuda, PhD
Z
Zoya Haitov Ben Zikri, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here