Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
Impact of Preemptive Analgesia on Postoperative Pain in Patients Undergoing Orthognathic Surgery: A Randomized Controlled Trial.
This randomized controlled clinical trial evaluates the effect of preemptive analgesia on postoperative pain outcomes in adult patients undergoing orthognathic surgery. Participants scheduled for bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia will be randomized to one of three groups: intravenous acetaminophen, intravenous ibuprofen, or a control group receiving standard postoperative analgesia without preoperative medication.
The study aims to determine whether the administration of pre-surgical analgesics reduces postoperative pain intensity and analgesic requirements during the early postoperative period. Pain will be assessed using a standardized pain scale at multiple time points following surgery, and secondary outcomes will include postoperative analgesic consumption and patient satisfaction with pain control.
This investigation seeks to contribute evidence supporting multimodal analgesic strategies and improved postoperative pain management in patients undergoing orthognathic surgery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Effective management of postoperative pain remains an important component of perioperative care in patients undergoing orthognathic surgery. Procedures such as bilateral sagittal split osteotomy and Le Fort I osteotomy are associated with significant postoperative discomfort due to extensive manipulation of osseous and soft tissue structures. Preemptive analgesia, defined as the administration of analgesic medication prior to surgical injury, has been proposed as a strategy to attenuate central sensitization and reduce postoperative pain intensity.
This study is designed as a participant-blinded, randomized controlled clinical trial conducted in the operating room at the Administration of Medical Services in Puerto Rico (ASEM). Adult patients between 21 and 65 years of age with American Society of Anesthesiologists (ASA) physical status I or II who are scheduled to undergo orthognathic surgery will be invited to participate following informed consent. A total of 72 participants will be enrolled and randomly assigned in a 1:1:1 ratio to one of three groups: intravenous acetaminophen, intravenous ibuprofen, or a control group receiving no preoperative analgesic intervention.
Participants in the intervention groups will receive either acetaminophen 1 g intravenously or ibuprofen 600 mg intravenously approximately 30 minutes before surgical incision, with a second dose administered near the end of the procedure according to the medication half-life. The control group will receive no pre-surgical analgesic administration and will follow the institution's standard postoperative pain management protocol.
Postoperative pain intensity will be measured using a validated pain scale at predetermined intervals during the postoperative period. Additional outcomes include postoperative analgesic requirements and patient satisfaction with pain control. By comparing two commonly used intravenous analgesic medications with standard care, this study aims to evaluate the effectiveness of preemptive analgesic strategies in improving postoperative pain outcomes and reducing analgesic consumption following orthognathic surgery.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dennys Rivera Pérez, MD
- Número de teléfono: 1920-1921 7877582525
- Correo electrónico: dennys.rivera@upr.edu
Copia de seguridad de contactos de estudio
- Nombre: Alvara J Horta Caicedo, DMD
- Número de teléfono: 1-678-394-7721
- Correo electrónico: alvaro.horta@upr.edu
Ubicaciones de estudio
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San Juan, Puerto Rico, 00936
- Administración de Servicios Médicos (ASEM)
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Contacto:
- Dennys Rivera Pérez, MD
- Número de teléfono: 1920-1921 7877582525
- Correo electrónico: dennys.rivera@upr.edu
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Contacto:
- Alvara J Horta Caicedo, DMD
- Número de teléfono: 1-678-394-7721
- Correo electrónico: alvaro.horta@upr.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 21 to 65 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled to undergo orthognathic surgery including bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia.
- Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Known allergy or intolerance to acetaminophen, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs).
- Renal dysfunction, defined as estimated glomerular filtration rate <60 mL/min/1.73 m².
- Hepatic dysfunction, defined as liver enzyme levels greater than twice the upper limit of normal.
- History of bleeding disorders or coagulopathy.
- Active or recent peptic ulcer disease.
- Current use of recreational drugs, including cannabis, that in the judgment of the investigators could interfere with anesthesia management, postoperative pain assessment, or study outcomes.
- Any medical condition that, in the judgment of the investigators, would make participation unsafe or interfere with study participation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intravenous Acetaminophen
Participants randomized to this arm will receive acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia.
A second dose will be administered near the end of the surgical procedure according to the medication half-life.
Postoperative pain outcomes will be compared with the other study groups.
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Acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia.
A second dose will be administered near the end of the surgical procedure according to the medication half-life.
Otros nombres:
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Experimental: Intravenous Ibuprofen
Participants randomized to this arm will receive ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia.
A second dose will be administered near the end of the procedure according to the medication half-life.
Postoperative pain outcomes will be compared with the other study groups.
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Ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia.
A second dose will be administered near the end of the surgical procedure according to the medication half-life.
Otros nombres:
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Sin intervención: Standard Care Control
Participants randomized to this arm will not receive preoperative analgesic medication.
Postoperative pain management will follow the institution's standard care protocol after completion of the surgical procedure.
Outcomes will be compared with participants receiving preemptive intravenous analgesic interventions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Postoperative Pain Intensity
Periodo de tiempo: 1 hour, 4 hours, and 24 hours after surgery
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Postoperative pain intensity measured using a validated pain scale (Visual Analog Scale, 0-10) in patients undergoing orthognathic surgery.
Pain scores will be recorded and compared between the acetaminophen, ibuprofen, and control groups.
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1 hour, 4 hours, and 24 hours after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Postoperative Analgesic Consumption
Periodo de tiempo: Within 24 hours after surgery
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Total amount of rescue analgesic medications administered during the postoperative period will be recorded and compared between study groups.
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Within 24 hours after surgery
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Patient Satisfaction with Pain Management
Periodo de tiempo: 24 hours after surgery
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Patient satisfaction with postoperative pain control measured using the Spanish version of the Pain Treatment Satisfaction Scale (PTSS).
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24 hours after surgery
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Cillo JE Jr, Dattilo DJ. Pre-emptive analgesia with pregabalin and celecoxib decreases postsurgical pain following maxillomandibular advancement surgery: a randomized controlled clinical trial. J Oral Maxillofac Surg. 2014 Oct;72(10):1909-14. doi: 10.1016/j.joms.2014.05.014. Epub 2014 May 27.
- Alyahya A, Aldubayan A, Swennen GRJ, Al-Moraissi E. Effectiveness of different protocols to reduce postoperative pain following orthognathic surgery: A systematic review and meta-analysis. Br J Oral Maxillofac Surg. 2022 Sep;60(7):e1-e10. doi: 10.1016/j.bjoms.2022.03.013. Epub 2022 Apr 23.
- Xuan C, Yan W, Wang D, Li C, Ma H, Mueller A, Chin V, Houle TT, Wang J. Efficacy of preemptive analgesia treatments for the management of postoperative pain: a network meta-analysis. Br J Anaesth. 2022 Dec;129(6):946-958. doi: 10.1016/j.bja.2022.08.038. Epub 2022 Oct 26.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Complicaciones Postoperatorias
- Procesos Patológicos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor Postoperatorio
- Químicos orgánicos
- Ácidos carboxílicos
- Aniluros
- Amidas
- Compuestos anilina
- Amina
- Acetanilidas
- Ácidos, carbocíclicos
- Fenilpropionatos
- Paracetamol
- Ibuprofeno
Otros números de identificación del estudio
- 2603555595
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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