Comparing lidocaine and regional anesthesia for pain management after scoliosis surgery
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
This study is testing whether using lidocaine or a specific regional anesthesia technique can help reduce pain and the need for morphine in patients aged 12 and older after scoliosis surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 12 Years to 25 Years |
| Sex | All |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Locations | 1 site (Be’er Ya‘aqov) |
| Trial ID | NCT06451562 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of lidocaine instillation versus regional anesthesia using the Erector spinae plane technique in reducing morphine consumption and managing pain after scoliosis repair surgery. Patients aged 12 and older, who are scheduled for the surgery, will be randomized into three groups: a control group receiving standard general anesthesia, a group receiving the Erector spinae plane block, and a group receiving lidocaine. The study will assess pain intensity, side effects, and recovery quality during the first 48 hours post-surgery. The goal is to minimize opioid use and its associated side effects.
Who should consider this trial
Good fit: Ideal candidates are patients over the age of 12 scheduled for scoliosis surgery who can independently operate a patient-controlled analgesia device.
Not a fit: Patients with chronic pain requiring opioid treatment, those with severe systemic insufficiencies, or those unable to consent or operate the PCA device will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for opioids and improve recovery outcomes for patients undergoing scoliosis surgery.
How similar studies have performed: Other studies have shown promising results with regional anesthesia techniques in reducing opioid consumption, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Where this trial is running
Be’er Ya‘aqov
- Shamir (Asaf Harofe) Medical Center — Be’er Ya‘aqov, Israel (Recruiting)
Study contacts
- Study coordinator: Sara Bar Yehuda, PhD
- Email: sarabar1@shamir.gov.il
- Phone: 972528981004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.