ArticleBMJ open2026
Comparison of oxycodone hydrochloride injection versus sufentanil for postoperative analgesia in patients undergoing minimally invasive cardiac valve replacement: study protocol for a single-centre, randomised, double-blind non-inferiority trial.
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionWith the advancement of the ERAS (Enhanced Recovery After Surgery) concept, minimally invasive heart valve replacement surgery has become widely performed due to its advantages of smaller trauma and fewer adverse reactions. However, postoperative pain management remains complex and traditional opioid analgesia is often associated with adverse side effects. Oxycodone, an opioid agonist, has strong analgesic effects with relatively few side effects. This study aims to explore the efficacy and safety of oxycodone hydrochloride injection in multimodal pain management following minimally invasive heart valve replacement surgery. METHODS AND ANALYSIS: This is a prospective, double-blind, randomised controlled clinical trial designed as a non-inferiority study. The schedule of enrolment, interventions and outcome assessments is summarised in figure 2. The study period is from October 2024 to September 2027, and between 30 April 2026 and 31 October 2026, a total of 130 patients undergoing minimally invasive heart valve replacement surgery will be planned to recruit and randomly assign in a 1:1 ratio to receive either oxycodone hydrochloride injection or sufentanil for postoperative patient-controlled analgesia. The primary outcome is the Numerical Rating Scale pain score during coughing at 24 hours postoperatively. Secondary outcomes include measures of postoperative pain control, analgesic consumption, adverse events and recovery-related indicators. To address the risk of type I error due to multiple secondary outcomes, secondary endpoints are prespecified and categorised into key secondary outcomes and exploratory outcomes with corresponding statistical analysis strategies planned. This protocol is V.2.0, dated 29 December 2025. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University (XJTU1AF2024LSYY-389-04). The study will be conducted in accordance with the Declaration of Helsinki, and informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals, scientific conferences and appropriate public channels.
trial registrationChiCTR2400094930.
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