Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery

NCT07489001 | Recruiting FDA Drug FDA Device

• 1 other identifier: 09.2025.403
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Opioid-Free Anesthesia; Multimodal Analgesia; Erector Spinae Plane Block; ESP Block; Postoperative Pain; Opioid-Related Adverse Effects; Opioid Consumption; Lumbar Spine Surgery; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Opioid Consumption in the First 48 Hours

  Total cumulative opioid consumption (morphine equivalents) within the first 48 postoperative hours, recorded via intravenous patient-controlled analgesia (PCA) and rescue opioid boluses. This measure evaluates the analgesic effectiveness of opioid-free versus opioid-containing intraoperative anesthesia strategies.

  0-48 hours after surgery

Secondary Outcomes (15)

• Postoperative Pain Intensity Assessed by Numerical Rating Scale (NRS)

  0, 3, 6, 12, 24, and 48 hours postoperatively

• Incidence of Opioid-Related Adverse Effects

  0-48 hours

• Postoperative Complications According to the Clavien-Dindo Classification

  Within 30 days after surgery

• Time to First Analgesic Request

  Postoperative period (assessed every 6 hours during the first 48 hours after arrival in the recovery unit)

• Total Non-Opioid Analgesic Consumption

  0-48 hours

Study Arms (3)

Group 1- Opioid-Based Anesthesia Group

Patients receiving intraoperative opioid-based analgesia without ESP or other truncal regional anesthesia techniques.

Drug: Opioid based Anesthesia; Device: Intraoperative ANI Monitoring; Device: Bispectral Index Monitoring

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.

Drug: Opioid-free Anesthesia; Procedure: Erector Spinae Plane Block; Device: Intraoperative ANI Monitoring; Device: Bispectral Index Monitoring

Group 3- ESP Block + Opioid Group

Patients receiving ultrasound-guided erector spinae plane (ESP) block plus intraoperative opioid analgesia such as remifentanil or morphine.

Procedure: Erector Spinae Plane Block; Drug: Opioid based Anesthesia; Device: Intraoperative ANI Monitoring; Device: Bispectral Index Monitoring

Interventions

Opioid-free Anesthesia DRUG

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)

Also known as: OFA

Group 2- Opioid-Free Anesthesia Group

Erector Spinae Plane Block PROCEDURE

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)

Also known as: ESP, ESPB, L-ESPB, L-ESP

Group 2- Opioid-Free Anesthesia Group; Group 3- ESP Block + Opioid Group

Opioid based Anesthesia DRUG

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)

Also known as: OBA, Conventional opioid anesthesia

Group 1- Opioid-Based Anesthesia Group; Group 3- ESP Block + Opioid Group

Intraoperative ANI Monitoring DEVICE

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.

Also known as: ANI, ANI monitoring

Group 1- Opioid-Based Anesthesia Group; Group 2- Opioid-Free Anesthesia Group; Group 3- ESP Block + Opioid Group

Bispectral Index Monitoring DEVICE

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.

Also known as: BIS, BIS Monitoring

Group 1- Opioid-Based Anesthesia Group; Group 2- Opioid-Free Anesthesia Group; Group 3- ESP Block + Opioid Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 to 75 years undergoing elective lumbar spine surgery for conditions such as lumbar spinal stenosis, lumbar disc herniation, degenerative spondylolisthesis, or lumbar disc degeneration at Marmara University Pendik Training and Research Hospital. All participants are surgical patients who meet the clinical indication for lumbar spinal procedures. No healthy volunteers are included. Patients are assigned to one of three observational cohorts based on the anesthesia technique chosen by the attending anesthesiologist in routine clinical practice.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara university hospital

Istanbul, Maltepe, 34722, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Degeneration; Pain, Postoperative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• burcu Akyüz irfanoğlu, MD

  marmara university hospital

  PRINCIPAL INVESTIGATOR

• seniyye ülgen zengin, MD

  marmara university hospital

  STUDY CHAIR

• meliha orhon ergün, MD

  marmara university hospital

  STUDY DIRECTOR

Central Study Contacts

Burcu Akyüz Irfanoğlu, MD

CONTACT

900-555-725-9649; brcakyz1@gmail.com

Seniyye Ulgen zengin, MD

CONTACT

900-505-714-2443; ulgen_t@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, Principal Investigator

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: March 23, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)