About this trial
This prospective, observational, non-randomized clinical study aims to evaluate the intraoperative and postoperative effects of opioid-free multimodal anesthesia compared with opioid-containing anesthesia methods in adult patients undergoing lumbar spinal surgery. Patients will be managed according to routine clinical practice and assigned to one of three groups based on the analgesic strategy used by the attending anesthesiologist: (1) opioid-free anesthesia using multimodal agents and/or erector spinae plane (ESP) block; (2) ESP block plus intraoperative opioids; or (3) opioid-based anesthesia without regional blocks.
The primary objective is to compare postoperative pain control and opioid requirements within the first 48 hours after surgery. Secondary objectives include evaluating opioid-related side effects such as nausea, vomiting, pruritus, constipation, delayed mobilization, urinary retention, and postoperative complications classified according to the Clavien-Dindo system. Standard postoperative analgesia, including intravenous morphine patient-controlled analgesia (PCA), acetaminophen, and NSAIDs, will be provided for all patients.
The study aims to determine whether an opioid-free multimodal analgesic approach can reduce opioid consumption and related adverse effects while maintaining adequate analgesia in patients undergoing lumbar spinal surgery.
Eligibility criteria
Qualifiers
Adults aged 18 to 75 years
Elective surgery only
Scheduled for elective lumbar spinal surgery (lumbar spinal stenosis and/or lumbar disc herniation)
ASA physical status I-III
Disqualifiers
Age younger than 18 or older than 75
Inability or unwillingness to provide informed consent
Severe psychiatric disease or cognitive impairment
Emergency surgery cases
Trial design
Treatments tested in this trial
- Opioid-free Anesthesia
- Erector Spinae Plane Block
- Opioid based Anesthesia
- Intraoperative ANI Monitoring
- Bispectral Index Monitoring