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Die klinische Studie NCT07489001 für Lumbale Spinalstenose, Lumbar Disc Herniation With Radiculopathy, Lumbar Degenerative Spondylolisthesis, Lumbar Disc Degeneration ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery 75 Randomisiert Beobachtend

Offene Rekrutierung
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Die klinische Studie NCT07489001 ist eine beobachtungsstudie zur Untersuchung von Lumbale Spinalstenose, Lumbar Disc Herniation With Radiculopathy, Lumbar Degenerative Spondylolisthesis, Lumbar Disc Degeneration und hat den Status offene rekrutierung. Die Studie startete am 9. Dezember 2025 und soll 75 Teilnehmer aufnehmen. Durchgeführt von Marmara-Universität ist der Abschluss für 10. Dezember 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 23. März 2026 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Ausführliche Beschreibung
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-...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
Lumbale SpinalstenoseLumbar Disc Herniation With RadiculopathyLumbar Degenerative SpondylolisthesisLumbar Disc Degeneration
Weitere Studien-IDs
  • 09.2025.403
NCT-Nummer
NCT07489001
Studienbeginn (tatsächlich)
2025-12-09
Zuletzt aktualisiert
2026-03-23
Studienende (vorauss.)
2026-12-10
Geplante Rekrutierung
75
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Stichwörter
Opioid-Free Anesthesia
Multimodal Analgesia
Erector Spinae Plane Block
ESP Block
Postoperative Pain
Opioid-Related Adverse Effects
Opioid Consumption
Lumbar Spine Surgery
Regional Anesthesia
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
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-Blockade
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-Blockade
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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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)
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • 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 logoMarmara-Universität100 aktive klinische Studien zum Erkunden
Verantwortliche Partei
Ulgen Zengin, Hauptprüfer, Associate Professor of Anesthesiology, Principal Investigator, Marmara University
Zentrale Studienkontakte
Kontakt: Burcu Akyüz Irfanoğlu, MD, 900-555-725-9649, [email protected]
Kontakt: Seniyye Ulgen zengin, MD, 900-505-714-2443, [email protected]
1 Studienstandorte in 1 Ländern

Maltepe

Marmara university hospital, Istanbul, Maltepe, 34722, Turkey (Türkiye)
BURCU Akyüz İrfanoğlu, MD, Kontakt, 900-505-714-2443, [email protected]
Seniyye Ulgen zengin, MD, Kontakt, 900-505-714-24-43, [email protected]
Meliha Orhon Ergün, MD, Prüfarzt
Burcu Akyüz Irfanoğlu, MD, Prüfarzt
Seniyye Ulgen Zengin, MD, Hauptprüfer
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