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.
BACKGROUND: Lumbar spine surgery is associated with significant postoperative pain, which can delay recovery and increase complications. Regional anesthesia techniques, specifically retrolaminar blocks, may provide superior analgesia compared to systemic opioids alone. STUDY DESIGN: This is a prospective, randomized, controlled trial conducted at Clínica Universidad de Los Andes, Chile. Patients will be allocated using variable block randomization (block sizes 4 and 6) in a 1:1 ratio. INTERVENTIONS: All patients will receive standardized general anesthesia (Propofol, Remifentanil, Rocuronium) and multimodal analgesia including paracetamol, metamizol, ketorolac, morphine, and pregabalin. The intervention group will additionally receive bilateral ultrasound-guided retrolaminar blocks with ropivacaine 0.5% (20 ml per side) at the end of surgery. OUTCOMES: Primary outcome is cumulative morphine consumption via patient-controlled analgesia (PCA) during the first 24 postoperative hours. Secondary outcomes include pain scores (VAS 0-10) at 0, 6, 12, 24, 48, and 72 hours; time to first rescue analgesia; duration of sensory block; incidence of nausea/vomiting; hospital length of stay; time to ambulation; sleep quality; patient satisfaction; adverse events; and development of chronic pain at 3 and 6 months. SAMPLE SIZE: 50 patients (25 per group) provides 80% power to detect a clinically significant difference in opioid consumption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Patients 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.
Patients receive standard multimodal analgesia without regional anesthesia block.
Clínica Universidad de los Andes, Chile
Santiago, Santiago Metropolitan, Chile
Total postoperative opioid consumption
Cumulative morphine consumption (in mg morphine equivalents) delivered via patient-controlled analgesia (PCA) pump during the first 24 postoperative hours
Time frame: First 24 hours after surgery
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
Time frame: Time in minutes from end of surgery until first request for rescue analgesia Time Frame: From end of surgery up to 72 hours
Duration of Sensory Block
Duration in hours from block performance until complete sensory recovery assessed by thermal and tactile testing
Time frame: From block performance up to 72 hours
Time to First Rescue Analgesia
Time in minutes from end of surgery until first request for rescue analgesia
Time frame: From end of surgery up to 24 hours
Incidence of PONV
Incidence of postoperative nausea and vomiting (PONV) requiring antiemetic rescue medication
Time frame: First 24 hours postoperatively
Length of hospital stay
Total number of days from hospital admission to discharge
Time frame: From admission to discharge, assessed up to 30 days
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