- Design
- Double-blind randomised non-inferiority and superiority trial
- Population
- 132 adults (ASA I–III) after elective gynaecological laparoscopy
- Primary outcome
- 48-hour pain on coughing (AUC) and QoR-15
- Effect
- Pain difference 6 (95% CI −8 to 20), non-inferior; QoR-15 +8 (4 to 12)
In this double-blind trial from China, 134 adults having elective gynaecological laparoscopy were randomised to patient-controlled intravenous analgesia with esketamine 1 mg/kg plus dexmedetomidine 3 µg/kg, or sufentanil 2 µg/kg, over 48 hours.
Pain on coughing was non-inferior with the opioid-free regimen (area under the pain curve 175 vs 169; difference 6, 95% CI −8 to 20; margin 24). Quality of recovery was better (QoR-15 116 vs 108; difference 8, 4–12), mainly through physical comfort and emotional state. No serious adverse events occurred.
Postoperative nausea, vomiting and dizziness are the main complaints after laparoscopic gynaecological surgery, and this regimen addressed recovery without losing analgesia. It is a single small trial in one surgical population, and esketamine availability varies; racemic ketamine is the more available alternative, but it was not what was tested.
- Consider opioid-sparing or opioid-free patient-controlled regimens after laparoscopic gynaecological surgery
- Monitor for sedation and bradycardia when combining dexmedetomidine infusions with other sedatives
- Watch for dissociative or psychotomimetic effects with ketamine-class agents
- Measure quality of recovery, not only pain scores, when auditing regimens
Why it matters
Opioid side-effects rather than pain drive poor recovery after laparoscopy, and this showed they can be avoided without losing analgesia.
The statistics, in plain English
Non-inferiority means the new regimen was not worse than the standard by more than a set margin — here the upper limit of the difference (20) stayed below the margin (24). An 8-point QoR-15 gain exceeds the roughly 6-point change usually considered meaningful to patients.
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