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

NCT07588802 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 2026P000949
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pain Management; Opoid Managment

Keywords

Opioid-sparing anesthesia; Opioid consumption; postoperative pain; elderly patients; spine surgery

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Total morphine equivalent consumption during the first 24 hours after surgery

  From end of surgery to 24 hours after surgery

Secondary Outcomes (11)

• Pain Scores (NRS)

  From end of surgery to postoperative 72 hours

• Time to First Rescue Analgesia

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

• Total Analgesic Consumption

  From end of surgery to postoperative 72 hours

• Time to first postoperative flatus

  Up to 72 hours postoperatively

• Quality of recovery

  At 1 day after surgery

Study Arms (2)

Group 1：Opioid-Sparing Anesthesia

EXPERIMENTAL

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

Group 2：Routine Anesthesia

ACTIVE COMPARATOR

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

Interventions

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.

Group 1：Opioid-Sparing Anesthesia

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.

Group 2：Routine Anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (6)

• 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.

  PMID: 41814842 BACKGROUND

• 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.

  PMID: 41527017 BACKGROUND

• 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.

  PMID: 39709188 BACKGROUND

• 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.

  PMID: 39262217 BACKGROUND

• 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.

  PMID: 40625006 BACKGROUND

• 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.

  PMID: 26827847 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share