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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
Location: See location...
Intervention Type: Procedure, Drug, Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Marmara university hospital
RECRUITING
Istanbul
Contact Information
Primary
Burcu Akyüz Irfanoğlu, MD
brcakyz1@gmail.com
900-555-725-9649
Backup
Seniyye Ulgen zengin, MD
ulgen_t@yahoo.com
900-505-714-2443
Time Frame
Start Date: 2025-12-09
Estimated Completion Date: 2026-12-10
Participants
Target number of participants: 75
Treatments
Group 1- Opioid-Based Anesthesia Group
Patients receiving intraoperative opioid-based analgesia without ESP or other truncal regional anesthesia techniques.
Group 2- Opioid-Free Anesthesia Group
Patients receiving opioid-free multimodal anesthesia, with or without ESP block, and non-opioid agents such as acetaminophen, lidocaine, ketamine, dexmedetomidine, magnesium sulfate, and esmolol.
Group 3- ESP Block + Opioid Group
Patients receiving ultrasound-guided erector spinae plane (ESP) block plus intraoperative opioid analgesia such as remifentanil or morphine.
Sponsors
Leads: Marmara University

This content was sourced from clinicaltrials.gov