Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery
Prospective Comparative Evaluation of Intra-operative and Postoperative Outcomes Associated With Opioid Free Versus Opioid Based Anesthesia Techniques in Patients Undergoing Elective Lumbar Spinal Surgery
Marmara University
75 participants
Dec 9, 2025
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria9
- 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
- No previous lumbar spine surgery
- Able to provide written informed consent
- BIS monitoring available and recorded
- Ability to comply with postoperative pain assessment (NRS/VAS)
- Stable hemodynamic status preoperatively
Exclusion Criteria19
- Age younger than 18 or older than 75
- Inability or unwillingness to provide informed consent
- Severe psychiatric disease or cognitive impairment
- Emergency surgery cases
- BMI \> 40 kg/m²
- Pregnancy
- Uncontrolled hypertension, arrhythmia, or severe cardiac disease
- Renal failure
- Chronic beta-blocker use
- Coagulation disorders
- Chronic alcohol dependence or substance use
- Neurological deficits affecting perception of pain
- Chronic pain syndrome (fibromyalgia, chronic LBP \> 3 months)
- Chronic gabapentinoid use
- Anemia
- Known allergy to any anesthetic or analgesic agents used in the study
- Local infection at the intended ESP block injection site
- Intraoperative change in anesthetic technique that deviates from initial planned management
- Pediatric patients (\<18 years)
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Interventions
A multimodal opioid-free anesthetic regimen including ESP block and agents such as acetaminophen, lidocaine, dexmedetomidine, ketamine, magnesium sulfate, and esmolol. No intraoperative opioids are given. Applies to Groups:Group 1 (Opioid-Free Anesthesia Group)
Before surgery, after endotracheal intubation of the patient in the prone position, a bilateral ultrasound-guided erector spinae plane block was performed at the vertebral level above the surgical site, using 20 mL of 0.25% bupivacaine per side in the lumbar region." Applies to Groups: * Group 2 (for patients who receive ESP) * Group 3 (ESP + Opioid Group)
Intraoperative opioid analgesia (e.g., remifentanil infusion and/or morphine) administered according to standard clinical practice. Applies to Groups: * Group 3 (ESP + Opioid Group) * Group 1 (Opioid-Based Anesthesia Group)
The Analgesia Nociception Index (ANI) device is used intraoperatively to continuously assess autonomic nervous system responses to nociceptive stimuli. ANI values are recorded in all participants and compared across anesthetic cohorts for evaluation of intraoperative analgesic adequacy.
Continuous intraoperative depth of anesthesia monitoring using the Bispectral Index (BIS) device. BIS values are recorded throughout the procedure to assist in titration of anesthetic agents and to standardize anesthesia depth across study cohorts. The BIS device is used for monitoring only, and no device-related investigational procedures are performed.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07489001