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Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery

Recruitingn/aAges 18 Years - 75 YearsAllMarmara University
NCT07489001 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, uri

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Opioid-free Anesthesia
  • Erector Spinae Plane Block
  • Opioid based Anesthesia
  • Intraoperative ANI Monitoring
  • Bispectral Index Monitoring
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Where

1 site
Marmara university hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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