Lumbar Spinal StenosisNCT07489001
Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery
An observational study of Lumbar Spinal Stenosis and Lumbar Disc Herniation With Radiculopathy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Disc Herniation With Radiculopathy, Lumbar Degenerative Spondylolisthesis
- What is being tested?
- Opioid-free Anesthesia, Erector Spinae Plane Block and Opioid based Anesthesia
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2025to 10 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- BIS monitoring available and recorded
- Ability to comply with postoperative pain assessment (NRS/VAS)
- Stable hemodynamic status preoperatively
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara university hospital
Istanbul, Maltepe, 34722
BURCU Akyüz İrfanoğlu, MD, 900-505-714-2443, brcakyz1@gmail.com
Seniyye Ulgen zengin, MD, 900-505-714-24-43, ulgen_t@yahoo.com
About this study
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
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.
Read the 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
- Being tested
- Opioid-free Anesthesia, Erector Spinae Plane Block, Opioid based Anesthesia, Intraoperative ANI Monitoring, Bispectral Index Monitoring
- 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
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Degeneration, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-free AnesthesiaDrug
Also called OFA
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 BlockProcedure or surgery
Also called ESP, ESPB, L-ESPB, L-ESP
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 AnesthesiaDrug
Also called OBA, Conventional opioid 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 MonitoringDevice
Also called ANI, 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 MonitoringDevice
Also called BIS, BIS 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Opioid-Based Anesthesia Group | Patients receiving intraoperative opioid-based analgesia without ESP or other truncal regional anesthesia techniques. Receives: 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. Receives: 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. Receives: Procedure: Erector Spinae Plane Block; Drug: Opioid based Anesthesia; Device: Intraoperative ANI Monitoring; Device: Bispectral Index Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-48 hours after surgery
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Intraoperative period
Patient Satisfaction Score
Patient-reported satisfaction with postoperative analgesia evaluated on a 0-3 scale (poor, moderate, good, very good).
Measured: At 48 hours postoperatively
Length of Post-operative Hospital Stay
Total duration of postoperative hospitalization measured in days.
Measured: 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
Measured: 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).
Measured: Intraoperative Period
Intraoperative Oxygenation and Ventilation Parameters
Oxygen saturation (SpO₂) and end-tidal carbon dioxide (ETCO₂) values recorded at predefined intraoperative intervals.
Measured: 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).
Measured: 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.
Measured: Intraoperative period (from induction of anesthesia, assessed every 30 minutes until the end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start9 Dec 2025
- Primary completion9 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulgen Zengin, Marmara University
- Investigators
- burcu Akyüz irfanoğlu, MD, Principal investigator, marmara university hospitalseniyye ülgen zengin, MD, Study chair, marmara university hospitalmeliha orhon ergün, MD, Study director, marmara university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489001
- Sponsor's protocol ID
- 09.2025.403
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07489001
- Acronym / sponsor ID
- 09.2025.403
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1- Opioid-Based Anesthesia Group | – | Drug: Opioid based Anesthesia, Device: Intraoperative ANI Monitoring, Device: Bispectral Index MonitoringPatients receiving intraoperative opioid-based analgesia without ESP or other truncal regional anesthesia techniques. |
| Group 2- Opioid-Free Anesthesia Group | – | Drug: Opioid-free Anesthesia, Procedure: Erector Spinae Plane Block, Device: Intraoperative ANI Monitoring, Device: Bispectral Index MonitoringPatients 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 | – | Procedure: Erector Spinae Plane Block, Drug: Opioid based Anesthesia, Device: Intraoperative ANI Monitoring, Device: Bispectral Index MonitoringPatients receiving ultrasound-guided erector spinae plane (ESP) block plus intraoperative opioid analgesia such as remifentanil or morphine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid-free AnesthesiaAlso: OFAA 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) | Drug | Group 2- Opioid-Free Anesthesia Group |
| Erector Spinae Plane BlockAlso: ESP, ESPB, L-ESPB, L-ESPBefore 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) | Procedure or surgery | Group 2- Opioid-Free Anesthesia Group, Group 3- ESP Block + Opioid Group |
| Opioid based AnesthesiaAlso: OBA, Conventional opioid anesthesiaIntraoperative 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) | Drug | Group 1- Opioid-Based Anesthesia Group, Group 3- ESP Block + Opioid Group |
| Intraoperative ANI MonitoringAlso: ANI, ANI monitoringThe 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 | Group 1- Opioid-Based Anesthesia Group, Group 2- Opioid-Free Anesthesia Group, Group 3- ESP Block + Opioid Group |
| Bispectral Index MonitoringAlso: BIS, BIS MonitoringContinuous 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. | Device | Group 1- Opioid-Based Anesthesia Group, Group 2- Opioid-Free Anesthesia Group, Group 3- ESP Block + Opioid Group |
Primary outcome
Postoperative Opioid Consumption in the First 48 Hours
Time frame: 0-48 hours after surgery
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.
15 secondary outcomes
Postoperative Pain Intensity Assessed by Numerical Rating Scale (NRS)
Time frame: 0, 3, 6, 12, 24, and 48 hours postoperatively
Incidence of Opioid-Related Adverse Effects
Time frame: 0-48 hours
Postoperative Complications According to the Clavien-Dindo Classification
Time frame: Within 30 days after surgery
Time to First Analgesic Request
Time frame: Postoperative period (assessed every 6 hours during the first 48 hours after arrival in the recovery unit)
Total Non-Opioid Analgesic Consumption
Time frame: 0-48 hours
Time to First Mobilization
Time frame: From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours
Return of Bowel Function
Time frame: Time from the end of surgery to the first documented bowel movement, assessed within the first 48 postoperative hours
Intraoperative Heart Rate
Time frame: Intraoperative period
Patient Satisfaction Score
Time frame: At 48 hours postoperatively
Length of Post-operative Hospital Stay
Time frame: 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
Time frame: hroughout the intraoperative period
Intraoperative Blood Pressure
Time frame: Intraoperative Period
Intraoperative Oxygenation and Ventilation Parameters
Time frame: Intraoperative period
Intraoperative Bispectral Index (BIS) Values
Time frame: Intraoperative period
Intraoperative Urine Output
Time frame: Intraoperative period (from induction of anesthesia, assessed every 30 minutes until the end of surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
burcu Akyüz irfanoğlu, MD principal investigator
marmara university hospital
seniyye ülgen zengin, MD study chair
marmara university hospital
meliha orhon ergün, MD study director
marmara university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis and Lumbar Disc Herniation With Radiculopathy, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burcu Akyüz Irfanoğlu, MD (900-555-725-9649, brcakyz1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Opioid Consumption in the First 48 Hours (time frame: 0-48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.