Primary outcomes and anticipated effect sizes in randomised clinical trials assessing adjuncts to peripheral nerve blocks: A scoping review
Authors' conclusion
The reported outcomes and associated anticipated effect sizes can be used in future trials on adjuncts for peripheral nerve blocks to increase methodological homogeneity.
Study context
- Population
- RCTs assessing adjuncts for single-shot ultrasound-guided peripheral nerve blocks published in 10 major anaesthesia journalsof 11,854 screened trials
- Participants
- 59 participants
- Comparison
- Adjunct vs placebo/no adjunct vs Adjunct vs active comparator
- Primary endpoint
- Choice of primary outcomes and corresponding anticipated effect size used for sample size estimation
Primary result
As reported in the abstract
Duration of analgesia as primary outcome (most frequent): anticipated effect sizes
| Group | Value | Relative median (IQR) anticipated effect size |
|---|---|---|
| Adjunct vs placebo/no adjunct | median 240 (IQR 180–318) min | 30% (25-40) |
| Adjunct vs active comparator | median 210 (IQR 180–308) min | 17% (15-28) |
Value
Adjunct vs placebo/no adjunctmedian 240 (IQR 180–318) min
Adjunct vs active comparatormedian 210 (IQR 180–308) min
Relative median (IQR) anticipated effect size
Adjunct vs placebo/no adjunct30% (25-40)
Adjunct vs active comparator17% (15-28)
- Duration of analgesia was the most frequent primary outcome
- 35/59 trials, 59%
Secondary outcomes
Adequate sample size calculations reported
- Trials reporting adequate sample size calculations
- 78%
Statistically significant primary outcome results
- Trials with statistically significant primary outcome results
- 45/59 trials (76%)
- Of these, did not reach the anticipated effect size
- 22%
Original publication
Primary outcomes and anticipated effect sizes in randomised clinical trials assessing adjuncts to peripheral nerve blocks: A scoping review. Acta Anaesthesiol Scand. Published 8 July 2024. doi:10. 1111/ aas. 14489
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