- Design
- Randomised, double-blind, parallel-group trial (registered)
- Population
- 94 women (92 analysed) having elective caesarean delivery
- Primary outcome
- Incidence of postoperative nausea and vomiting within 48 hours
- Effect
- 6.5% vs 23.9%; RR 0.27 (95% CI 0.08 to 0.91)
This double-blind trial randomised 94 women having elective caesarean delivery to patient-controlled intravenous analgesia with tegileridine (5 mg) or sufentanil (100 micrograms). Tegileridine is a biased mu-opioid receptor agonist. Ninety-two completed the study.
Nausea and vomiting within 48 hours occurred in 6.5% on tegileridine and 23.9% on sufentanil (RR 0.27, 95% CI 0.08 to 0.91; absolute difference -17.4%, 95% CI -31.6 to -3.1%). Dizziness was also lower (6.5% vs 26.1%). Pain scores, bolus counts, rescue analgesia, ambulation time and hospital stay did not differ significantly. Quality of Recovery-15 scores at 48 hours were higher with tegileridine (median 125 vs 113).
The interval around the main result is wide and its upper limit approaches 1, so this is a signal needing confirmation. The authors themselves call for larger multicentre studies before routine adoption.
- Do not change obstetric analgesia on this trial alone; it enrolled 92 women.
- Remember that analgesic efficacy was similar between groups, so the difference was in side effects.
- Continue standard multimodal analgesia and antiemetic prophylaxis after caesarean delivery.
- Check whether tegileridine is available and licensed where you work before considering it.
Why it matters
Opioid side effects, not pain control, are what many women complain of after caesarean delivery.
Don't overread it
A small trial; the primary result is imprecise and no conclusions can be drawn about respiratory depression or breastfeeding.
The statistics, in plain English
A relative risk of 0.27 with a confidence interval from 0.08 to 0.91 is a large but imprecise effect; with about 46 women per arm, a few events either way would change the result. Differences in secondary outcomes can arise by chance.
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