Opioid-free versus opioid-based anesthesia for elective lumbar spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational, non-randomized comparison of three anesthetic approaches used in routine care for adult elective lumbar spine surgery. Patients are assigned to one of three groups based on the attending anesthesiologist's choice: opioid-free multimodal anesthesia (±ESP block), ESP block plus intraoperative opioids, or opioid-based anesthesia without regional blocks. Primary outcomes are postoperative pain scores and opioid consumption in the first 48 hours; secondary outcomes include opioid-related side effects and postoperative complications classified by Clavien-Dindo. Perioperative monitoring such as BIS and ANI are recorded, and standard inclusion/exclusion criteria apply.

Why it matters

Who can join: the full rules

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)

Where it's running

• Marmara university hospital
  Istanbul, Maltepe, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: burcu Akyüz irfanoğlu, MD — marmara university hospital
• Study coordinator: Burcu Akyüz Irfanoğlu, MD
• Email: brcakyz1@gmail.com
• Phone: 900-555-725-9649

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.