Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Elderly Patients Undergoing Spine Surgery
2 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
120
Fase
- Fase 2
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Opioid consumption
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Scores (NRS)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de abril de 2027
Finalización del estudio (Estimado)
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2026
Publicado por primera vez (Actual)
15 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026P000949
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data (IPD) will not be shared due to concerns about patient privacy and the sensitive nature of the data collected.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .