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NCT Number: NCT07489001

Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara university hospital

Istanbul, Maltepe, 34722, Turkey (Türkiye)

Location status: Recruiting

Location contact

BURCU Akyüz İrfanoğlu, MD

CONTACT

[email protected]

900-505-714-2443

Burcu Akyüz Irfanoğlu, MD

SUB_INVESTIGATOR

Meliha Orhon Ergün, MD

SUB_INVESTIGATOR

Seniyye Ulgen Zengin, MD

PRINCIPAL_INVESTIGATOR

Seniyye Ulgen zengin, MD

CONTACT

[email protected]

900-505-714-24-43

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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)

Other names: OFA

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)

Other names: ESP, ESPB, L-ESPB, L-ESP

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)

Other names: OBA, Conventional opioid anesthesia

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.

Other names: ANI, ANI monitoring

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.

Other names: BIS, BIS Monitoring

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Pain Intensity Assessed by Numerical Rating Scale (NRS)

    Time frame: 0, 3, 6, 12, 24, and 48 hours postoperatively

    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.

  2. Incidence of Opioid-Related Adverse Effects

    Time frame: 0-48 hours

    Presence of nausea, vomiting, pruritus, constipation, urinary retention, sedation, and respiratory depression. Adverse effects will be compared among the three anesthesia groups.

  3. Postoperative Complications According to the Clavien-Dindo Classification

    Time frame: Within 30 days after surgery

    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.

  4. Time to First Analgesic Request

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

    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.

  5. Total Non-Opioid Analgesic Consumption

    Time frame: 0-48 hours

    Total amount of non-opioid analgesics administered postoperatively (e.g., acetaminophen, NSAIDs), including rescue doses.

  6. Time to First Mobilization

    Time frame: From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours

    Time from the end of surgery to the patient's first ambulation, as documented by the clinical team, measured in postoperative hours.

  7. 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

    Time to the first documented bowel movement measured in postoperative hours and the presence or absence of constipation during the postoperative period.

  8. Intraoperative Heart Rate

    Time frame: Intraoperative period

    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).

  9. Patient Satisfaction Score

    Time frame: At 48 hours postoperatively

    Patient-reported satisfaction with postoperative analgesia evaluated on a 0-3 scale (poor, moderate, good, very good).

  10. 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

    Total duration of postoperative hospitalization measured in days.

  11. Intraoperative Analgesia Nociception Index (ANI) Values

    Time frame: hroughout the intraoperative period

    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

  12. Intraoperative Blood Pressure

    Time frame: Intraoperative Period

    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).

  13. Intraoperative Oxygenation and Ventilation Parameters

    Time frame: Intraoperative period

    Oxygen saturation (SpO₂) and end-tidal carbon dioxide (ETCO₂) values recorded at predefined intraoperative intervals.

  14. Intraoperative Bispectral Index (BIS) Values

    Time frame: Intraoperative period

    BIS values recorded at predefined intraoperative intervals.(baseline before induction, after induction, after intubation, and every 30 minutes thereafter until the end of surgery).

  15. Intraoperative Urine Output

    Time frame: Intraoperative period (from induction of anesthesia, assessed every 30 minutes until the end of surgery)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burcu Akyüz Irfanoğlu, MD

CONTACT

[email protected]

900-555-725-9649

Seniyye Ulgen zengin, MD

CONTACT

[email protected]

900-505-714-2443

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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