Effect of intraperitoneal ropivacaine during and after cytoreductive surgery on time-interval to adjuvant chemotherapy in advanced ovarian cancer: a randomised, double-blind phase III trial
Primary result · RIOTResult — go to the resultMean difference 0.7 days CI −2.2 to 3.4Authors' conclusion
Intraperitoneal local anaesthetic did not shorten the time to RIOT among women undergoing surgery for advanced ovarian cancer in this trial.
Study context
- Population
- Women >18 yr with advanced ovarian cancer scheduled for cytoreductive surgery, ASA 1–3, Sweden175 in modified ITT analysis
- Participants
- 225 women
- Comparison
- Intraperitoneal ropivacaine 0.2% vs saline 0.9% during and after surgery
- Ropivacainen = 113
- Placebon = 112reference
- Primary endpoint
- Time to return to intended oncologic therapy (RIOT)
Methodological detailsdouble-blind, phase III, parallel, superiority, placebo-controlled, two university hospitals
- Double-blind
- Phase III
- Parallel
- Superiority
- Placebo-controlled
- Two university hospitals
Primary result
RIOT
Mean difference
0.7 days
CI −2.2 to 3.4
P = 0.65
By group
Ropivacaine vs Placebo
mean difference 0.7 days (CI −2.2 to 3.4); P = 0.65
As reported in the abstract
Further findings
Return to intended oncologic therapy (RIOT), per-protocol analysis
- Per-protocol mean difference in RIOT, similar results
- 0.5 days (−2.4 to 3.4 days; P=0.74)
- Per-protocol analysis of 166 women
Short-term recovery
- No differences in short-term recovery
Safety
- No differences in postoperative morbidity
Original publication
Effect of intraperitoneal ropivacaine during and after cytoreductive surgery on time-interval to adjuvant chemotherapy in advanced ovarian cancer: a randomised, double-blind phase III trial. Br J Anaesth. Published 20 November 2024. doi:10. 1016/ j. bja. 2024. 10. 015
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