NCT07489001

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lumbar spinal surgery, including lumbar canal stenosis and lumbar disc herniation procedures, is frequently associated with significant postoperative pain. Opioids are commonly used for perioperative analgesia; however, they may lead to several adverse effects such as nausea, vomiting, pruritus, constipation, urinary retention, delayed mobilization, and, less commonly, respiratory depression. In recent years, opioid-sparing and opioid-free multimodal analgesia strategies have gained increasing interest in an effort to minimize these side effects while maintaining effective pain control. This prospective, observational, non-randomized study will evaluate the intraoperative and postoperative outcomes of three different anesthetic approaches routinely used in clinical practice for adult patients undergoing lumbar spinal surgery. Patients will be allocated into groups based on the independent decision of the attending anesthesiologist; the research team will not influence the anesthesia plan. Group 1 (Opioid-free anesthesia): Patients receive multimodal analgesia (including agents such as acetaminophen, lidocaine, magnesium sulfate, ketamine, esmolol, and dexmedetomidine) and may undergo an erector spinae plane (ESP) block or other trunk blocks. No intraoperative opioids are administered. Group 2 (ESP + opioid group): Patients receive an ESP block and multimodal analgesia, with the addition of intraoperative opioids such as remifentanil or morphine, as determined by the anesthesiologist. Group 3 (Opioid-based anesthesia): Patients receive opioid-containing analgesia without the use of ESP or other truncal regional blocks. All patients will receive standardized postoperative analgesia according to institutional guidelines, including intravenous morphine via patient-controlled analgesia (PCA), acetaminophen, and NSAIDs. Rescue analgesia will be provided as needed with intravenous morphine, acetaminophen, or tramadol. Data will be collected regarding demographics, intraoperative hemodynamic parameters, anesthesia medications, intraoperative opioid and non-opioid consumption, urine output, depth of anesthesia (BIS), and surgery duration. Postoperative assessments will include pain scores (VAS and NRS at 0, 3, 6, 12, 24, and 48 hours), total opioid consumption, time to first analgesic request, patient satisfaction, postoperative complications, bowel function, mobilization time, urine output, vital signs, and length of stay. Complications will be classified using the Clavien-Dindo system to allow standardized comparison of postoperative morbidity across groups. The primary objective of the study is to determine whether an opioid-free multimodal analgesia regimen provides effective postoperative pain control and reduces opioid requirements compared with opioid-containing strategies. Secondary objectives include evaluating the incidence of opioid-related adverse effects and the overall quality of recovery. By systematically comparing these three routinely used anesthetic approaches, the study aims to clarify the potential benefits of opioid-free anesthesia in lumbar spine surgery and support evidence-based perioperative analgesia strategies.

Conditions

• Lumbar Spinal Stenosis
• Lumbar Disc Herniation With Radiculopathy
• Lumbar Degenerative Spondylolisthesis
• Lumbar Disc Degeneration

Interventions

Type	Name	Description
DRUG	Opioid-free Anesthesia	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)
PROCEDURE	Erector Spinae Plane Block	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)
DRUG	Opioid based Anesthesia	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)
DEVICE	Intraoperative ANI Monitoring	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.
DEVICE	Bispectral Index Monitoring	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.

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-12-09
• Completion: 2026-12-10
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study
• FDA-regulated device study