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Opoid ManagmentPhase 2NCT07588802

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

A Phase 2 study testing Opioid-Sparing Protocol and Routine anesthesia protocol in people with Opoid Managment and Pain Management, run by Massachusetts General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Opoid Managment, Pain Management
What is being tested?
Opioid-Sparing Protocol and Routine anesthesia protocol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Sep 2026to May 2027
Phase
Phase 2
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • 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

About this study

Official title: 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?

Read more

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.

Being tested
Opioid-Sparing Protocol, Routine anesthesia protocol
Keywords
Opioid-sparing anesthesia, Opioid consumption, postoperative pain, elderly patients, spine surgery
Medical subject headings
Agnosia, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opioid-Sparing ProtocolDrug

    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 protocolDrug

    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.

Study groups in NCT07588802
Study groupRoleWhat they receive
Group 1：Opioid-Sparing AnesthesiaExperimentalParticipants 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.
Receives: Drug: Opioid-Sparing Protocol
Group 2：Routine AnesthesiaActive comparatorParticipants 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.
Receives: Drug: Routine anesthesia protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid consumption

    Total morphine equivalent consumption during the first 24 hours after surgery

    Measured: From end of surgery to 24 hours after surgery

Secondary outcomes (11)

  1. Pain Scores (NRS)

    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.

    Measured: From end of surgery to postoperative 72 hours

  2. Time to First Rescue Analgesia

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

    Measured: From end of surgery to the administration of the first rescue analgesic

  3. Total Analgesic Consumption

    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.

    Measured: From end of surgery to postoperative 72 hours

  4. Time to first postoperative flatus

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

    Measured: Up to 72 hours postoperatively

  5. Quality of recovery

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

    Measured: At 1 day after surgery

  6. Sleep quality

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

    Measured: From end of surgery to 3 days after surgery

  7. Postoperative anxiety

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

    Measured: From end of surgery to 2 days after surgery

  8. Postoperative delirium

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

    Measured: From end of surgery to 3 days after surgery

  9. Length of Hospital Stay

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

    Measured: Through hospital discharge, up to 14 days

  10. Adverse Effects

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

    Measured: From end of surgery to 3 days after surgery

  11. Gut microbiota

    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.

    Measured: From 1 day before surgery to 2 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07588802
Sponsor's protocol ID
2026P000949
Status last verified
May 2026
First submitted
5 May 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to concerns about patient privacy and the sensitive nature of the data collected.

Publications

  • Xu M, Zhu R, She YJ, Sun Y, Xu L, Rosenquist R, Yao M, Han X, Xu J. Perioperative Ketamine and Esketamine for Enhanced Recovery After Surgery (ERAS): A Systematic Review. J Invest Surg. 2026 Dec;39(1):2637241. doi: 10.1080/08941939.2026.2637241. Epub 2026 Mar 11.

    PubMed 41814842

  • Sun Y, Yao Y, Li Y, Deng W. Dexmedetomidine for opioid-sparing postoperative analgesia: a systematic review and meta-analysis. BMC Anesthesiol. 2026 Jan 13;26(1):103. doi: 10.1186/s12871-025-03606-w.

    PubMed 41527017

  • Ervin-Sikhondze BA, Gunaseelan V, Chua KP, Bicket MC, Waljee JF, Englesbe MJ, Brummett CM. Opioid consumption in the first 30 days after surgery was independently associated with new persistent opioid use. Reg Anesth Pain Med. 2026 Mar 5;51(3):317-323. doi: 10.1136/rapm-2024-106068.

    PubMed 39709188

  • Mathew J, Gum JL, Carreon LY, Sampedro BC, Harpe-Bates J, Hines BP, Brown ME, Daniels CL, Mkorombindo T, Glassman SD. Opioid Sparing Anesthesia for Adult Spinal Deformity Surgery Reduces Postoperative Pain, Length of Stay, Opioid Consumption, and Opioid-Related Complications: A Propensity-Matched Analysis. Spine (Phila Pa 1976). 2025 Jun 15;50(12):804-808. doi: 10.1097/BRS.0000000000005159. Epub 2024 Sep 12.

    PubMed 39262217

  • Yu C, Madsen M, Akande O, Oh MY, Mattie R, Lee DW. Narrative Review on Postoperative Pain Management Following Spine Surgery. Neurospine. 2025 Jun;22(2):403-420. doi: 10.14245/ns.2550410.205. Epub 2025 Jun 30.

    PubMed 40625006

  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

    PubMed 26827847

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Opioid-Sparing Protocol and Routine anesthesia protocol in people with Opoid Managment and Pain Management, run by Massachusetts General Hospital.

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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid consumption (time frame: From end of surgery to 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07588802, which also lists 6 linked publications.

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 8 Sep 2026.

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