Clinical Trial Radar

Name: 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
Creator: Marmara University
Published: 2026-03-23
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07489001 for Lumbar Spinal Stenosis, Lumbar Disc Herniation With Radiculopathy, Lumbar Degenerative Spondylolisthesis, Lumbar Disc Degeneration is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery 75 Randomized Observational

Recruiting

Clinical Trial NCT07489001 is an observational study for Lumbar Spinal Stenosis, Lumbar Disc Herniation With Radiculopathy, Lumbar Degenerative Spondylolisthesis, Lumbar Disc Degeneration that is recruiting. It started on 9 December 2025 with plans to enroll 75 participants. Led by Marmara University, it is expected to complete by 10 December 2026. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.

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 a...Show More

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-...Show More

Official Title

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

Conditions

Lumbar Spinal StenosisLumbar Disc Herniation With RadiculopathyLumbar Degenerative SpondylolisthesisLumbar Disc Degeneration

Other Study IDs

09.2025.403

NCT ID Number

NCT07489001

Start Date (Actual)

2025-12-09

Last Update Posted

2026-03-23

Completion Date (Estimated)

2026-12-10

Enrollment (Estimated)

Study Type

Observational

Status

Recruiting

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

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
Group 1- Opioid-Based Anesthesia Group Patients receiving intraoperative opioid-based analgesia without ESP or other truncal regional anesthesia techniques.	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) 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. 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.
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.	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) 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) 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. 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.
Group 3- ESP Block + Opioid Group Patients receiving ultrasound-guided erector spinae plane (ESP) block plus intraoperative opioid analgesia such as remifentanil or morphine.	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) 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) 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity Assessed by Numerical Rating Scale (NRS)	Pain intensity will be measured using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Assessments will be recorded at predefined postoperative time points.	0, 3, 6, 12, 24, and 48 hours postoperatively
Incidence of Opioid-Related Adverse Effects	Presence of nausea, vomiting, pruritus, constipation, urinary retention, sedation, and respiratory depression. Adverse effects will be compared among the three anesthesia groups.	0-48 hours
Postoperative Complications According to the Clavien-Dindo Classification	Postoperative complications will be graded according to the Clavien-Dindo classification system (Grade I-V). Any deviation from the normal postoperative course will be recorded and classified, and the highest Clavien-Dindo grade observed during the follow-up period will be used for analysis.Complications were prospectively recorded and classified according to the Clavien-Dindo classification.	Within 30 days after surgery
Time to First Analgesic Request	Time elapsed from arrival in the recovery unit to the first patient request for additional analgesia, with analgesic requests recorded at 6-hour intervals over a 48-hour postoperative period.	Postoperative period (assessed every 6 hours during the first 48 hours after arrival in the recovery unit)
Total Non-Opioid Analgesic Consumption	Total amount of non-opioid analgesics administered postoperatively (e.g., acetaminophen, NSAIDs), including rescue doses.	0-48 hours
Time to First Mobilization	Time from the end of surgery to the patient's first ambulation, as documented by the clinical team, measured in postoperative hours.	From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours
Return of Bowel Function	Time to the first documented bowel movement measured in postoperative hours and the presence or absence of constipation during the postoperative period.	Time from the end of surgery to the first documented bowel movement, assessed within the first 48 postoperative hours
Intraoperative Heart Rate	Heart rate measured in beats per minute (bpm), recorded at predefined intraoperative intervals (baseline before induction, after induction, after intubation and every 30 minutes thereafter until the end of surgery).	Intraoperative period
Patient Satisfaction Score	Patient-reported satisfaction with postoperative analgesia evaluated on a 0-3 scale (poor, moderate, good, very good).	At 48 hours postoperatively
Length of Post-operative Hospital Stay	Total duration of postoperative hospitalization measured in days.	Length of postoperative hospital stay, defined as the time from the end of surgery to hospital discharge, assessed up to 30 days postoperatively
Intraoperative Analgesia Nociception Index (ANI) Values	Analgesia Nociception Index (ANI) values recorded intraoperatively to assess autonomic response to nociceptive stimuli. ANI values will be compared between groups and correlated with intraoperative hemodynamic parameters and postoperative pain scores (NRS/VAS). This outcome evaluates the potential predictive value of ANI monitoring in differentiating analgesic effectiveness across anesthesia strategies.T	hroughout the intraoperative period
Intraoperative Blood Pressure	Systolic, diastolic, and mean arterial blood pressure measured in mmHg, recorded at predefined intraoperative intervals (baseline before induction,after induction, after intubation, and every 30 minutes thereafter until the end of surgery).	Intraoperative Period
Intraoperative Oxygenation and Ventilation Parameters	Oxygen saturation (SpO₂) and end-tidal carbon dioxide (ETCO₂) values recorded at predefined intraoperative intervals.	Intraoperative period
Intraoperative Bispectral Index (BIS) Values	BIS values recorded at predefined intraoperative intervals.(baseline before induction, after induction, after intubation, and every 30 minutes thereafter until the end of surgery).	Intraoperative period
Intraoperative Urine Output	Urine output measured in milliliters (mL) at predefined 30-minute intraoperative intervals following induction of anesthesia, as an indicator of intraoperative renal perfusion and fluid balance.	Intraoperative period (from induction of anesthesia, assessed every 30 minutes until the end of surgery)

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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

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)

Marmara University

Study Responsible Party

Ulgen Zengin, Principal Investigator, Associate Professor of Anesthesiology, Principal Investigator, Marmara University

Study Central Contact

Contact: Burcu Akyüz Irfanoğlu, MD, 900-555-725-9649, [email protected]

Contact: Seniyye Ulgen zengin, MD, 900-505-714-2443, [email protected]

1 Study Locations in 1 Countries

Turkey (Türkiye)

Maltepe

Marmara university hospital, Istanbul, Maltepe, 34722, Turkey (Türkiye)

BURCU Akyüz İrfanoğlu, MD, Contact, 900-505-714-2443, [email protected]

Seniyye Ulgen zengin, MD, Contact, 900-505-714-24-43, [email protected]

Meliha Orhon Ergün, MD, Sub-Investigator

Burcu Akyüz Irfanoğlu, MD, Sub-Investigator

Seniyye Ulgen Zengin, MD, Principal Investigator

Recruiting

Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery 75 Randomized Observational

Inclusion Criteria

Exclusion Criteria