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A Multicentre Cluster Randomised Stepped Wedge Trial of Opioid Sparing Analgesia in Emergency General Surgery
Chao Ren1, Shicao Li1, Tian Zhang1
1Department of Pharmacy, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.
Background:
Emergency general surgery (EGS) is associated with high postoperative pain burden and historically relies on opioid-centric analgesia, which can delay recovery and increase opioid-related adverse events and longer-term exposure. Evidence for scalable, system-level opioid-sparing pathways in pragmatic emergency surgical settings remains limited, particularly in Asian tertiary health systems.
Methods:
We conducted a pragmatic, multicentre and cluster-randomised stepped-wedge trial in 12 Chinese tertiary hospitals comparing usual care with a structured multimodal opioid-sparing perioperative analgesia pathway. The primary outcome was cumulative 48-h postoperative opioid consumption (oral morphine milligram equivalents, MME). Secondary outcomes assessed pain, recovery, safety and post-discharge opioid exposure. Mixed-effects models accounted for clustering and period effects.
Results:
Of 3646 enrolled patients, primary outcome data were available for 3561 (97.7%). Mean 48-h opioid consumption decreased from 64.2 to 46.1 MME, with an adjusted reduction of -18.1 MME (95% CI = -21.4 to -14.7; p < 0.001) and a ratio of means of 0.76 (95% CI = 0.72-0.80; p < 0.001). High opioid exposure (> 100 MME) declined (17.2% vs. 9.9%; OR = 0.52), while opioid-free status at 48 h increased (8.0% vs. 17.7%; OR = 2.47) (both p < 0.001). Pain burden, recovery metrics, opioid-related adverse events and persistent opioid use at 30 days all favoured the intervention.
Conclusions:
A structured opioid-sparing pathway reduced early postoperative opioid exposure and improved recovery and safety outcomes in EGS, supporting wider implementation of multimodal opioid stewardship.
