Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery (NCT07489001) | Clinical Trial Compass
RecruitingNot Applicable
Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery
Turkey (Türkiye)75 participantsStarted 2025-12-09
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Opioid Consumption in the First 48 Hours