- Design
- randomised, triple-masked, placebo-controlled trial with dual primary outcomes
- Population
- 50 adults undergoing outpatient percutaneous nephrolithotomy, all receiving a single-injection erector spinae plane block
- Primary outcome
- average daily pain intensity and cumulative opioid consumption over postoperative days 1-2
- Effect
- pain 3.5 against 3.0 (estimated difference 0.25, 95% CI -1.0 to 1.5, P=0.538); oxycodone 10 mg against 15 mg (difference 0, -15 to 5, P=0.358)
Fifty adults having outpatient percutaneous nephrolithotomy all received an ultrasound-guided perineural catheter at the eighth transverse process and the same 20 ml of 0.25% bupivacaine with adrenaline through it. They were then randomised, triple-masked, to automated intermittent boluses of 21 ml of 0.25% bupivacaine or of saline every four hours for about 57 hours through a portable pump. The dual primary outcomes were pain severity and opioid consumption over the first two postoperative days.
Neither separated. Average daily pain was a median 3.5 with the active infusion against 3.0 with placebo (estimated difference 0.25, 95% CI -1.0 to 1.5, P=0.538). Cumulative oxycodone was 10 mg against 15 mg (estimated difference 0, 95% CI -15 to 5, P=0.358). Maximum daily pain, second-night sleep disturbance and pain interference on the Brief Pain Inventory were all the same.
The design deserves credit: everyone got the single-injection block, so the trial asked the question that actually arises in practice - is the catheter worth adding - rather than comparing a catheter against nothing. Fifty patients is small and the confidence intervals are wide enough to leave a modest benefit possible. But a continuous catheter after outpatient surgery carries real costs: the pump, the follow-up, the risk of catheter-related problems at home, and a patient discharged with an infusion. Against a point estimate of zero, that is a poor trade.
- Do not add a continuous erector spinae catheter to a single-injection block for outpatient PCNL as routine
- Keep the single-injection block - it was given to every patient in this trial and was not the thing being tested
- Note that pain was moderate in both groups (median 3.0-3.5, maximum around 7) - there is a real unmet analgesic need here that the catheter did not meet
- Where a catheter is used for other indications, this trial says nothing about those
- Weigh the logistics of discharging a patient with an infusion pump against a benefit this trial could not detect
Why it matters
It tests the increment that matters - catheter on top of block - rather than block against nothing.
Don't overread it
Fifty patients with wide confidence intervals: this excludes a large benefit, not a small one.
The statistics, in plain English
An estimated pain difference of 0.25 points with an interval of -1.0 to 1.5 tells you the true effect is somewhere between slightly worse and mildly better - with 25 patients per arm, a clinically meaningful benefit of around 1 point has not been excluded. This is therefore a null result rather than proof of no effect. What makes it actionable anyway is the direction: the point estimate favoured placebo on pain and the opioid difference was exactly zero, so there is no signal to pursue.
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