Actively Recruiting
Prospective Comparative Evaluation of Opioid-Free Versus Opioid-Based Anesthesia Techniques in Elective Lumbar Spinal Surgery
Led by Marmara University · Updated on 2026-03-23
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of opioid-free multimodal anesthesia compared with opioid-containing anesthesia in adults undergoing lumbar spinal surgery, including conditions like lumbar spinal stenosis and disc herniation. This observational study aims to compare postoperative pain control and opioid use within the first 48 hours after surgery, as well as opioid-related side effects and postoperative complications classified by the Clavien-Dindo system. Participants receive one of three anesthesia approaches based on the attending anesthesiologist's choice: opioid-free anesthesia using multimodal agents and possibly an erector spinae plane (ESP) block; ESP block combined with intraoperative opioids; or opioid-based anesthesia without regional blocks. All patients receive standard postoperative pain management including intravenous morphine patient-controlled analgesia, acetaminophen, and NSAIDs. The study also includes intraoperative monitoring with devices measuring analgesia depth and anesthesia. During the study, data will be collected on demographics, intraoperative medications and parameters, and surgery duration. Postoperative assessments include pain scores at multiple time points, total opioid use, time to first pain medication request, patient satisfaction, complications, bowel function, mobilization time, vital signs, and length of hospital stay. Safety and recovery quality are evaluated up to 30 days after surgery, with continuous monitoring of anesthesia depth and autonomic responses during surgery.
CONDITIONS
Brief Title
Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- 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 before surgery
You will not qualify if you...
- Younger than 18 or older than 75 years
- Unable or unwilling to provide informed consent
- Severe psychiatric disease or cognitive impairment
- Emergency surgery cases
- Body Mass Index over 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 pain perception
- Chronic pain syndrome lasting more than 3 months
- Chronic gabapentinoid use
- Anemia
- Known allergy to anesthetic or analgesic agents used
- Local infection at ESP block injection site
- Changes in anesthetic technique during surgery not following initial plan
- Pediatric patients under 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate post-operative period
Participants undergo elective lumbar spinal surgery with one of three anesthesia approaches: opioid-free multimodal anesthesia, opioid-based anesthesia, or opioid-based anesthesia combined with an erector spinae plane (ESP) block. Intraoperative monitoring includes analgesia nociception index and bispectral index monitoring to assess anesthesia depth and analgesic adequacy. Standardized postoperative pain management is provided in the recovery unit.
1 surgical procedure and continuous intraoperative monitoring
Duration - Up to 30 days after surgery
Participants are assessed for pain control, opioid consumption, time to first analgesic request, mobilization, bowel function, opioid-related adverse effects, patient satisfaction, and postoperative complications. Assessments occur repeatedly during the first 48 hours after surgery and complications are monitored up to 30 days postoperatively.
Multiple assessments over 48 hours and follow-up visits for up to 30 days
Trial Site Locations
Total: 1 location
1
Marmara university hospital
Istanbul, Maltepe, Turkey (Türkiye), 34722
Actively Recruiting
Research Team
B
Burcu Akyüz Irfanoğlu, MD
S
Seniyye Ulgen zengin, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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