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A Predictive Model for Postoperative Analgesic Requirements After Abdominal Surgery

2026년 9월 1일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

65

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Tsyr Xiang Teoh, Master of Anaesthesiology
  • 전화번호: +603-79494422
  • 이메일: teohtx@um.edu.my

연구 장소

      • Kuala Lumpur, 말레이시아, 59100
        • Universiti Malaya Medical Centre
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Rescue Analgesic Administration Events During the First 48 Hours After Abdominal Surgery
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Postoperative Pain Scores
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 1일

기본 완료 (추정된)

2027년 7월 1일

연구 완료 (추정된)

2028년 6월 1일

연구 등록 날짜

최초 제출

2026년 7월 25일

QC 기준을 충족하는 최초 제출

2026년 9월 1일

처음 게시됨 (실제)

2026년 9월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 1일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2026223-16373
  • NMRR ID-26-02772-RUY (레지스트리 식별자: NMRR)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .