Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Elderly Patients Undergoing Spine Surgery
2 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
120
Fase
- Fase 2
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
|
Actieve vergelijker: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Opioid consumption
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain Scores (NRS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
1 april 2027
Studie voltooiing (Geschat)
1 mei 2027
Studieregistratiedata
Eerst ingediend
5 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 mei 2026
Eerst geplaatst (Werkelijk)
15 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 september 2026
Laatste update ingediend die voldeed aan QC-criteria
2 september 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026P000949
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data (IPD) will not be shared due to concerns about patient privacy and the sensitive nature of the data collected.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .