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Effect of the local anaesthetic ropivacaine intraperitoneally during and after cytoreductive surgery on time-interval to adjuvant chemotherapy in advanced ovarian cancer: a randomised, double-blind phase III trial

Hasselgren, Emma ; Groes-Kofoed, Nina ; Falconer, Henrik ; Bjorne, Hakan ; Zach, Diana ; Hunde, Daniel ; Johansson, Hemming ; Asp, Mihaela LU orcid ; Kannisto, Päivi LU and Gupta, Anil , et al. (2024) In British Journal of Anaesthesia p.1-9
Abstract
Background
In a previous phase II trial, intraperitoneal local anaesthetics shortened the time interval between surgery and adjuvant chemotherapy, an endpoint associated with improved survival in advanced ovarian cancer. Our objective was to test this in a phase III trial.
Methods
A double-blind, phase III parallel superiority trial was conducted at two university hospitals in Sweden, within a public and centralised healthcare system. Women >18 yr with advanced ovarian cancer scheduled for cytoreductive surgery, an ASA physical status of 1–3 with no speech/language issues, were eligible. Participants were randomly assigned using a central computerised system to receive either ropivacaine 0.2% or saline 0.9% (placebo)... (More)
Background
In a previous phase II trial, intraperitoneal local anaesthetics shortened the time interval between surgery and adjuvant chemotherapy, an endpoint associated with improved survival in advanced ovarian cancer. Our objective was to test this in a phase III trial.
Methods
A double-blind, phase III parallel superiority trial was conducted at two university hospitals in Sweden, within a public and centralised healthcare system. Women >18 yr with advanced ovarian cancer scheduled for cytoreductive surgery, an ASA physical status of 1–3 with no speech/language issues, were eligible. Participants were randomly assigned using a central computerised system to receive either ropivacaine 0.2% or saline 0.9% (placebo) intraperitoneally during and after surgery. The primary endpoint was time to return to intended oncologic therapy (RIOT), analysed using t-test and linear regression adjusted for centre.
Results
Of the 225 women randomised between August 2020 and December 2023 (ropivacaine n=113; placebo n=112), 175 were included in the modified intention-to-treat analysis (ropivacaine n=86; placebo n=89). Median age: ropivacaine group 64 yr (56–73 yr), placebo group: 66 yr (57–74 yr). The mean RIOT in the ropivacaine group was 26.5 days vs 25.8 days in the placebo group, with a mean difference of 0.7 days (−2.2 to 3.4 days; P=0.65). Per-protocol analysis of 166 women yielded similar results, mean difference of 0.5 days (−2.4 to 3.4 days; P=0.74) days. There were no differences in short-term recovery or postoperative morbidity.
Conclusion
Intraperitoneal local anaesthetic did not shorten the time to RIOT among women undergoing surgery for advanced ovarian cancer in this trial. (Less)
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organization
publishing date
type
Contribution to journal
publication status
epub
subject
in
British Journal of Anaesthesia
pages
1 - 9
publisher
Elsevier
external identifiers
  • scopus:85209686406
ISSN
1471-6771
DOI
10.1016/j.bja.2024.10.015
language
English
LU publication?
yes
id
631dfedc-0689-40e0-8c2e-7a0b6c7dcd42
date added to LUP
2024-11-21 09:02:40
date last changed
2025-04-04 15:09:38
@article{631dfedc-0689-40e0-8c2e-7a0b6c7dcd42,
  abstract     = {{Background<br/>In a previous phase II trial, intraperitoneal local anaesthetics shortened the time interval between surgery and adjuvant chemotherapy, an endpoint associated with improved survival in advanced ovarian cancer. Our objective was to test this in a phase III trial.<br/>Methods<br/>A double-blind, phase III parallel superiority trial was conducted at two university hospitals in Sweden, within a public and centralised healthcare system. Women &gt;18 yr with advanced ovarian cancer scheduled for cytoreductive surgery, an ASA physical status of 1–3 with no speech/language issues, were eligible. Participants were randomly assigned using a central computerised system to receive either ropivacaine 0.2% or saline 0.9% (placebo) intraperitoneally during and after surgery. The primary endpoint was time to return to intended oncologic therapy (RIOT), analysed using t-test and linear regression adjusted for centre.<br/>Results<br/>Of the 225 women randomised between August 2020 and December 2023 (ropivacaine n=113; placebo n=112), 175 were included in the modified intention-to-treat analysis (ropivacaine n=86; placebo n=89). Median age: ropivacaine group 64 yr (56–73 yr), placebo group: 66 yr (57–74 yr). The mean RIOT in the ropivacaine group was 26.5 days vs 25.8 days in the placebo group, with a mean difference of 0.7 days (−2.2 to 3.4 days; P=0.65). Per-protocol analysis of 166 women yielded similar results, mean difference of 0.5 days (−2.4 to 3.4 days; P=0.74) days. There were no differences in short-term recovery or postoperative morbidity.<br/>Conclusion<br/>Intraperitoneal local anaesthetic did not shorten the time to RIOT among women undergoing surgery for advanced ovarian cancer in this trial.}},
  author       = {{Hasselgren, Emma and Groes-Kofoed, Nina and Falconer, Henrik and Bjorne, Hakan and Zach, Diana and Hunde, Daniel and Johansson, Hemming and Asp, Mihaela and Kannisto, Päivi and Gupta, Anil and Salehi, Sahar}},
  issn         = {{1471-6771}},
  language     = {{eng}},
  month        = {{11}},
  pages        = {{1--9}},
  publisher    = {{Elsevier}},
  series       = {{British Journal of Anaesthesia}},
  title        = {{Effect of the local anaesthetic ropivacaine intraperitoneally during and after cytoreductive surgery on time-interval to adjuvant chemotherapy in advanced ovarian cancer: a randomised, double-blind phase III trial}},
  url          = {{http://dx.doi.org/10.1016/j.bja.2024.10.015}},
  doi          = {{10.1016/j.bja.2024.10.015}},
  year         = {{2024}},
}