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

May 8, 2026 updated by: Jingping Wang, MD, Ph.D., Massachusetts General Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1：Opioid-Sparing Anesthesia
Participants assigned to Group 1 will receive opioid-sparing anesthesia strategy. Continuous intravenous infusion of ketamine (5 μg/kg/min) and dexmedetomidine (0.6 μg/kg/h) will be initiated from induction and maintained until one hour before the anticipated end of surgery. 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.
Drug: Opioid-Sparing Protocol
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.
Active Comparator: Group 2：Routine Anesthesia
Participants assigned to Group 2 will receive routine anesthesia management. During induction, fentanyl 100 μg will be administered intravenously. If needed during surgery, rescue analgesia with hydromorphone may be administered as clinically indicated.
Drug: Routine anesthesia protocol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: From end of surgery to 24 hours after surgery
Total morphine equivalent consumption during the first 24 hours after surgery
From end of surgery to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From end of surgery to postoperative 72 hours
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.
From end of surgery to the administration of the first rescue analgesic
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.
From end of surgery to postoperative 72 hours
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.
Up to 72 hours postoperatively
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.
At 1 day after surgery
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).
From end of surgery to 3 days after surgery
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).
From end of surgery to 2 days after surgery
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).
From end of surgery to 3 days after surgery
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.
Through hospital discharge, up to 14 days
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.
From end of surgery to 3 days after surgery
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.
From 1 day before surgery to 2 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026P000949

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to concerns about patient privacy and the sensitive nature of the data collected.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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