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NCT Number: NCT07588802

Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Elderly Patients Undergoing Spine Surgery

The goal of this clinical trial is to learn if an anesthesia management strategy called opioid-sparing anesthesia could help reduce postoperative opioid consumption, pain intensity and enhance recovery in elderly patients undergoing spine surgery. The main questions it aims to answer are:

Does opioid-sparing anesthesia reduce postoperative opioid consumption?

Dose opioid-sparing anesthesia improve postoperative pain and enhance recovery?

Researchers will compare opioid-sparing anesthesia to routine anesthesia which is used most common in clinical practice to see if opioid-sparing anesthesia lead to fewer postoperative opioid consumption and better pain and recovery outcomes.

Participants will randomly assigned to one of two groups. One group will receive opioid-sparing anesthesia management , while the other group will receive routine anesthesia management during general anesthesia.

Participants will provide two rectal swab samples for analysis, complete five questionnaires once preoperatively, and then complete five questionnaires daily for three days postoperatively.

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Key information

Conditions

Opoid Managment Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged ≥ 65 years
  • Undergoing multilevel level (≥2 levels) spine surgery under general anesthesia
  • Able to provide written informed consent

Exclusion criteria

  • Diagnosed with severe cognitive impairment or psychiatric disorders that impair participation or communication
  • Pregnant or breastfeeding
  • Patients with contraindications to any of the medications in the study protocol (unstable angina, recent myocardial infarction, cerebral or aortic aneurysms, increased intracranial pressure, increased intraocular pressure, psychosis or schizophrenia, pheochromocytoma, epilepsy, second- or third-degree atrioventricular block, bradycardia (heart rate < 50bpm), liver failure, hypotension (systolic BP <80 mmHg))
  • Drug or alcohol abuse
  • Refuse to participate

Treatment and study plan

Opioid-Sparing Protocol

Drug

The opioid-sparing anesthesia protocol consists of continuous intravenous infusion of ketamine (5 μg/kg/min) and dexmedetomidine (0.6 μg/kg/h) during general anesthesia. If needed during surgery, rescue analgesia with dexmedetomidine (0.4 μg/kg, i.v.) or ketamine (5 mg, i.v.) may be administered as clinically indicated.

Routine anesthesia protocol

Drug

Routine anesthesia consisting of standard general anesthetic management per institutional practice, which include opioid-based analgesia as clinically indicated, which is fentanyl 100 μg during induction, and if needed during surgery, rescue analgesia with hydromorphone may be administered as clinically indicated.

Primary outcomes

  1. Opioid consumption

    Time frame: From end of surgery to 24 hours after surgery

    Total morphine equivalent consumption during the first 24 hours after surgery

Secondary outcomes

  1. Pain Scores (NRS)

    Time frame: From end of surgery to postoperative 72 hours

    Pain intensity will be assessed after recovery and 1, 6, 24, 48, 72 hours after surgery using the Numeric Rating Scale (NRS) daily, including NRS at rest, NRS on movement.

  2. Time to First Rescue Analgesia

    Time frame: From end of surgery to the administration of the first rescue analgesic

    The exact time (in hours and minutes) from the end of surgery to the administration of the first rescue analgesic will be recorded.

  3. Total Analgesic Consumption

    Time frame: From end of surgery to postoperative 72 hours

    The cumulative amount of all pain medications (opioid and non-opioid, oral and intravenous) administered within 3 days postoperatively, including total morphine equivalent consumption during 48 hours and 72 hours after surgery.

  4. Time to first postoperative flatus

    Time frame: Up to 72 hours postoperatively

    The exact time (in hours and minutes) from the end of surgery to the first postoperative flatus will be recorded.

  5. Quality of recovery

    Time frame: At 1 day after surgery

    The quality of recovery after surgery will be evaluated using Quality of Recovery-15 (QoR-15) at 1 day after surgery.

  6. Sleep quality

    Time frame: From end of surgery to 3 days after surgery

    The sleep quality after surgery will be evaluated daily for the first 3 postoperative days using Richards-Campbell Sleep Questionnaire (RCSQ).

  7. Postoperative anxiety

    Time frame: From end of surgery to 2 days after surgery

    The anxiety after surgery will be evaluated daily for the first 2 postoperative days using Visual Analog Scale for Anxiety (NRS-anxiety).

  8. Postoperative delirium

    Time frame: From end of surgery to 3 days after surgery

    The postoperative delirium will be evaluated twice a day for the first 3 postoperative days using 3-Minute Diagnostic Interview for CAM (3D-CAM).

  9. Length of Hospital Stay

    Time frame: Through hospital discharge, up to 14 days

    Length of hospital stay measured as the number of days from the date of surgery to hospital discharge.

  10. Adverse Effects

    Time frame: From end of surgery to 3 days after surgery

    Incidence of nausea or vomiting, acute urinary retention, drowsiness, pruritus, and dizziness or any other reported complications will be recorded.

  11. Gut microbiota

    Time frame: From 1 day before surgery to 2 days after surgery

    Gut microbiota diversity (α and β), and correlation between relative abundance of specific microbial taxa and the effect of opioid-sparing anesthesia will be analyzed.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Spine Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
Jun 15, 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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