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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- Opioid-Based Anesthesia Group | Patients receiving intraoperative opioid-based analgesia without ESP or other truncal regional anesthesia techniques. |
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| 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. |
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| Group 3- ESP Block + Opioid Group | Patients receiving ultrasound-guided erector spinae plane (ESP) block plus intraoperative opioid analgesia such as remifentanil or morphine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| burcu Akyüz irfanoğlu, MD | marmara university hospital | Principal Investigator |
| seniyye ülgen zengin, MD | marmara university hospital | Study Chair |
| meliha orhon ergün, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara university hospital | Recruiting | Istanbul | Maltepe | 34722 | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared. The study involves clinical information collected under institutional ethical approval, and no consent was obtained for external sharing of identifiable or de-identified participant-level data.
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| 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:
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| Opioid based Anesthesia | Drug | Intraoperative opioid analgesia (e.g., remifentanil infusion and/or morphine) administered according to standard clinical practice. Applies to Groups:
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| 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. |
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| 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. |
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| 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) |
| marmara university hospital |
| Study Director |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D055959 | Intervertebral Disc Degeneration |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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