About this trial
This randomized controlled trial evaluates the effectiveness of ultrasound-guided retrolaminar nerve block in addition to standard multimodal analgesia for postoperative pain management in patients undergoing lumbar spine surgery. Fifty patients will be randomly assigned to receive either the retrolaminar block combined with standard pain management or standard pain management alone. The primary outcome is total opioid consumption in the first 24 hours after surgery. Secondary outcomes include pain intensity at multiple time points, time to first rescue analgesia, duration of sensory block, incidence of postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and chronic pain development at 3 and 6 months follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18-80 years
Scheduled for elective lumbar spine surgery (with instrumentation)
American Society of Anesthesiologists (ASA) physical status I-III
Willing and able to provide written informed consent
Disqualifiers
Refusal to participate in the study
Known allergy to local anesthetics (bupivacaine - levobupivacaine - lidocaine) or any study medication
Contraindication to regional anesthesia (infection at injection site, coagulopathy)
Chronic opioid use (daily use for >3 months prior to surgery)
Trial design
Parallel
Treatments tested in this trial
Ultrasound-Guided Retrolaminar Block
Procedure/SurgeryPatients will receive bilateral ultrasound-guided retrolaminar blocks with Bupivacaine 0.25% and Epinephrine 50mcg (15 ml total volume per side) before surgery. The block will be performed by an experienced anesthesiologist using real-time ultrasound guidance.
Standard Analgesia
Other interventionPatients receive standard multimodal analgesia without regional anesthesia block.
Treatment groups
Trial outcomes
Primary outcomes
Total postoperative opioid consumption
Cumulative morphine consumption (in mg morphine equivalents) delivered via patient-controlled analgesia (PCA) pump during the first 24 postoperative hours
Secondary outcomes
Pain Intensity
Pain intensity measured using Visual Analog Scale (VAS, 0-10 where 0=no pain and 10=worst imaginable pain) Time Frame: 0, 6, 12, 24, 48, and 72 hours postoperatively
Duration of Sensory Block
Duration in hours from block performance until complete sensory recovery assessed by thermal and tactile testing
Time to First Rescue Analgesia
Time in minutes from end of surgery until first request for rescue analgesia
Incidence of PONV
Incidence of postoperative nausea and vomiting (PONV) requiring antiemetic rescue medication
Other outcomes
Patient satisfaction
Patient satisfaction with pain management measured using 5-point Likert scale (1=very dissatisfied to 5=very satisfied)
Chronic Pain Development
Incidence of chronic pain defined as VAS \> 3 at surgical site
Sponsors and contacts
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