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A Predictive Model for Postoperative Analgesic Requirements After Abdominal Surgery

1 de septiembre de 2026 actualizado por: Chaw Sook Hui

Quantitative Analysis of Postoperative Analgesia Following Abdominal Surgery Using Repeated Time-to-Event Modelling of Rescue Analgesic Administration

Postoperative pain remains a common challenge after abdominal surgery despite the use of standard multimodal pain management strategies. Poorly controlled pain can delay recovery, limit early mobilisation, reduce patient comfort, and increase the risk of longer-term pain problems.

This study aims to develop a predictive model to better understand and anticipate patients' postoperative pain relief needs after abdominal surgery. The study will observe adults undergoing elective abdominal surgery and collect information on their pain scores, pain medication use, surgical characteristics, and recovery during the first 48 hours after surgery.

Participants will receive standard postoperative pain management according to usual clinical practice. The study will analyse patterns of rescue pain medication use, including when and how often additional pain relief is required after surgery. The collected information will be used to develop a model that can predict factors associated with increased pain medication requirements.

The goal of this research is to improve understanding of individual differences in postoperative pain and provide a foundation for more personalised pain management strategies in the future. The findings may help healthcare providers identify patients who are more likely to require additional pain relief and support the development of safer and more effective approaches to postoperative pain control.

Descripción general del estudio

Descripción detallada

Postoperative pain remains a significant clinical challenge following abdominal surgery. Although multimodal analgesic strategies are widely implemented, many patients continue to experience moderate-to-severe pain during the early postoperative period and require repeated rescue analgesic administration. Current approaches to evaluate postoperative analgesic requirements often rely on total opioid consumption or time to first rescue analgesia. However, these methods may not fully capture the dynamic and repeated nature of postoperative pain and analgesic demand.

This study aims to develop a predictive model to characterise postoperative analgesic requirements in adults undergoing elective abdominal surgery. The study will use repeated time-to-event pharmacokinetic-pharmacodynamic modelling to analyse the timing and pattern of rescue morphine administration during the first 48 hours after surgery.

This is a prospective observational cohort study involving adult patients undergoing elective open or laparoscopic abdominal surgery under general anaesthesia. Participants will receive standard postoperative analgesic management according to routine clinical practice. No changes to clinical care will be introduced as part of the study.

Data collected will include patient demographics, surgical characteristics, anaesthetic details, postoperative pain scores, and analgesic administration records. Rescue analgesic events will be captured from patient-controlled analgesia (PCA) device records, including the timing and dose of successful morphine administrations. Individual morphine exposure will be estimated using documented dosing histories and published population pharmacokinetic parameters.

The collected data will be analysed using repeated time-to-event pharmacokinetic-pharmacodynamic modelling. The model will evaluate factors influencing the likelihood of requiring rescue analgesia over time, including temporal patterns, circadian effects, morphine exposure, and patient or surgical characteristics. Model performance will be assessed using simulation-based evaluation methods, including predictive checks and bootstrap analysis.

The expected outcome of this study is the development of a validated predictive framework for postoperative analgesic requirements after abdominal surgery. This model may provide a foundation for future personalised analgesic strategies, allowing earlier identification of patients at higher risk of inadequate pain control and supporting safer, more effective postoperative pain management.

Tipo de estudio

De observación

Inscripción (Estimado)

65

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Tsyr Xiang Teoh, Master of Anaesthesiology
  • Número de teléfono: +603-79494422
  • Correo electrónico: teohtx@um.edu.my

Ubicaciones de estudio

      • Kuala Lumpur, Malasia, 59100
        • Universiti Malaya Medical Centre
        • Contacto:
          • SOOK HUI CHAW, PHD
          • Número de teléfono: +603-79494422
          • Correo electrónico: sh_chaw@um.edu.my

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
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Adults undergoing elective abdominal surgery under general anaesthesia will be enrolled in this prospective observational cohort study. The study population represents patients experiencing the early postoperative recovery phase, where pain trajectories and analgesic requirements vary substantially between individuals. Participants will be observed during the first 48 hours after surgery to characterise patterns of rescue analgesic use and postoperative pain.

The study aims to develop a predictive model of postoperative analgesic requirements by integrating analgesic administration patterns with patient and surgical characteristics. The findings will support a better understanding of individual variability in postoperative pain management and provide a foundation for future personalised analgesic strategies.

Descripción

Inclusion Criteria:

  • Adult patients aged 18-75 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Elective open or laparoscopic abdominal surgery under general anaesthesia
  • Expected postoperative ward or high-dependency unit (HDU) stay of ≥ 48 hours
  • Ability to provide written informed consent in Bahasa Malaysia or English
  • Ability to comprehend and self-report pain using the Numerical Rating Scale (NRS, 0-10)

Exclusion Criteria:

  • Chronic opioid therapy, defined as regular opioid use for ≥ 4 weeks prior to surgery
  • Severe hepatic impairment (Child-Pugh Class B or C) or severe renal impairment (eGFR < 30 mL/min/1.73 m²)
  • Known allergy or hypersensitivity to morphine or any opioid analgesic
  • Cognitive impairment (documented diagnosis of dementia or delirium), language barrier, or communication deficit precluding reliable NRS self-report
  • Documented history of substance use disorder (including opioid use disorder)
  • Withdrawal of informed consent at any point

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Adult Patients Undergoing Elective Abdominal Surgery
Adult patients aged 18-75 years undergoing elective open or laparoscopic abdominal surgery under general anaesthesia will be enrolled in this prospective observational cohort. Participants will receive standard postoperative analgesic management according to routine clinical practice. Rescue analgesia will be provided using intravenous morphine via patient-controlled analgesia (PCA), and the timing and dose of successful analgesic administrations will be recorded during the first 48 hours after surgery. Patient demographics, surgical characteristics, pain scores, and analgesic administration data will be collected to develop a predictive model of postoperative analgesic requirements.
Participants will receive intravenous morphine via patient-controlled analgesia (PCA) as part of standard postoperative analgesic management following elective abdominal surgery. The study does not assign or modify analgesic treatment. Morphine PCA usage, including timing and dose of successful administrations, will be recorded to characterise postoperative analgesic requirements using repeated time-to-event modelling.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rescue Analgesic Administration Events During the First 48 Hours After Abdominal Surgery
Periodo de tiempo: Up to 48 hours after completion of surgery
The number and timing of successful rescue analgesic events following elective abdominal surgery. A rescue analgesic event is defined as each successful patient-controlled analgesia (PCA) activation resulting in intravenous morphine delivery. The repeated occurrence and timing of rescue analgesic events will be analysed using repeated time-to-event modelling to characterise postoperative analgesic requirements.
Up to 48 hours after completion of surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative Pain Scores
Periodo de tiempo: At PACU arrival/ every 15 minutes during PACU stay/ every 4 hours up to 48 hours after surgery
Pain intensity measured using the Numerical Rating Scale (NRS; 0-10) at predefined postoperative time points, including before and after rescue analgesic administration.
At PACU arrival/ every 15 minutes during PACU stay/ every 4 hours up to 48 hours after surgery
Morphine Exposure and Relationship With Rescue Analgesic Hazard
Periodo de tiempo: Up to 48 hours after completion of surgery
Relationship between predicted morphine plasma concentration derived from individual dosing histories and the hazard of subsequent rescue analgesic administration.
Up to 48 hours after completion of surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

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

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 enero de 2027

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

25 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Publicado por primera vez (Actual)

3 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

A formal plan for sharing individual participant data has not yet been established. Any future data sharing will be considered after completion of the study, publication of the primary findings, and approval by the relevant institutional ethics committee. If data sharing is undertaken, only de-identified data will be considered, and access will be subject to appropriate data protection measures and institutional requirements.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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