Patient Refusal of Patient-Controlled Analgesia - Incidence, Associated Factors, and Reasons - A Prospective Mixed-Methods Cohort Study Protocol in a Chinese Tertiary Hospital

Aug 30, 2026

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Patient Refusal of Patient-Controlled Analgesia (PCA) remains insufficiently understood in China despite PCA’s recognized effectiveness for postoperative pain control. This prospective mixed-methods cohort protocol will enroll 4,000 eligible adult surgical patients in a Chinese tertiary hospital, measure sociodemographic, clinical, and cognitive determinants before standardized PCA recommendation, and analyze predictors of refusal using LASSO and multivariable logistic regression. Refusers will undergo semi-structured interviews with qualitative content analysis until saturation, with postoperative pain scores and decision regret also assessed. Results aim to guide targeted patient education and improve shared decision-making to enhance pain management and recovery outcomes.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages8

Reading Time20 min

AccessFree to download

Background

Methods

Study design and participants

Data collection and analysis

Discussion

Trial registration

Journal of Pain Research downloaded from [https://www.dovepress.com/](https://www.dovepress.com/) For personal use only. Journal of Pain Research Open Access Full Text Article STUDY PROTOCOL Patient Refusal of Patient-Controlled Analgesia: Incidence, Associated Factors, and Reasons—A Prospective Mixed-Methods Cohort Study Protocol in a Chinese Tertiary Hospital Yue Shen 1 , *, Guanyu Yang 1 , *, Jing Sang 1 , Liumei Li 1 , Jiayao Tian 2 , Zhentao Sun 3 , Qinjun Chu 1 1Department of Anesthesiology and Perioperative Medicine, Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, People’s Republic of China; 2The First Clinical Medical College, Lanzhou University, Lanzhou, Gansu, People’s Republic of China; 3Department of Anesthesiology, Pain and Perioperative Medicine, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, People’s Republic of China *These authors contributed equally to this work Correspondence: Zhentao Sun, Department of Anesthesiology, Pain and Perioperative Medicine, the First Affiliated Hospital of Zhengzhou University, Jianshe East Road 1, Zhengzhou, Henan, 450052, People’s Republic of China, Tel +8613603455483, Email [fccsunzt@zzu.edu.cn](fccsunzt@zzu.edu.cn); Qinjun Chu, Department of Anesthesiology and Perioperative Medicine, Zhengzhou Central Hospital Affiliated to Zhengzhou University, Tongbai North Road 16, Zhengzhou, Henan, 450007, People’s Republic of China, 450007, Email [jimmynetchu@163.com](jimmynetchu@163.com) | Background: Patient-controlled analgesia (PCA) is an effective method for managing postoperative pain, yet a significant number of eligible patients in China decline its use. The reasons for this refusal are not fully understood, limiting the development of patientcentered pain management strategies. This study aims to investigate the incidence, influencing factors, and underlying reasons for PCA refusal among surgical patients.
Methods: A prospective, mixed-methods cohort study will be conducted at a tertiary hospital in China. A total of 4,000 adult patients scheduled for surgery and eligible for PCA will be enrolled. Before the standard preoperative anesthesiology consultation, participants will complete a baseline assessment of sociodemographic, clinical, and cognitive factors related to PCA. After a standardized PCA recommendation, patients’ acceptance or refusal will be recorded. Quantitative data will first be analyzed using least absolute shrinkage and selection operator (LASSO) regression to select predictors; subsequently, multivariable logistic regression will be used to identify factors associated with refusal. Patients who refuse PCA will be invited to participate in semi-structured interviews to explore their decision-making motivations. Interviews will be documented through detailed written notes and analyzed using qualitative content analysis to identify the primary reasons for refusal; data collection will continue until saturation is reached. Postoperative pain scores and decision regret among refusers will also be assessed.
Discussion: This study will provide insights into PCA refusal from both quantitative and qualitative perspectives. The findings are expected to inform the development of targeted patient education programs and improve shared decision-making processes, ultimately enhancing postoperative pain management and recovery outcomes.
Trial Registration: Chinese Clinical Trial Registry (ChiCTR2600116056) . Registered on January 5, 2026.
Keywords: patient-controlled analgesia, postoperative pain, decision-making, mixed-methods, cohort study, factors | | --- | | Introduction
Postoperative acute pain is a common clinical issue that affects patient recovery and well-being.1 A large-scale, population-based study in China revealed that 48.7% of surgical patients endure moderate to severe pain in the postoperative period.1 Inadequately managed pain is not merely a source of suffering; it

FAQs

What is the primary objective of this study protocol?

To determine the incidence of PCA refusal and identify associated factors and underlying reasons among surgical patients in a Chinese tertiary hospital.

How will the study analyze factors linked to PCA refusal?

Quantitative predictors will be selected using LASSO regression, then multivariable logistic regression will estimate which factors are associated with refusal.

How will the researchers explore reasons for refusing PCA?

Patients who refuse PCA will participate in semi-structured interviews; responses will be analyzed using qualitative content analysis until data saturation is reached.

Aug 30, 2026

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