Evidence map›Paper›PMID 39572271›Full record

Trial reportBritish journal of anaesthesia2025

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.

Emma Hasselgren, Nina Groes-Kofoed, Henrik Falconer, Håkan Björne, Diana Zach, Daniel Hunde, Hemming Johansson, Mihaela Asp, Päivi Kannisto, Anil Gupta and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in British journal of anaesthesia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04065009 (A Randomized Double Blind, Multicenter Trial to Assess Time-interval Between Cytoreductive Surgery and Adjuvant Chemotherapy After Administration of Local Anesthetic Intraperitoneally/Perioperatively in Advanced Epithelial Ovarian Cancer), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04065009 phase3active not recruitingnot on this map

A Randomized Double Blind, Multicenter Trial to Assess Time-interval Between Cytoreductive Surgery and Adjuvant Chemotherapy After Administration of Local Anesthetic Intraperitoneally/Perioperatively in Advanced Epithelial Ovarian Cancer

TypeinterventionalSponsorKarolinska InstitutetRan2020 to 2028Enrolled220ConditionsAdvanced Ovarian CancerArmsRopivacaine, Saline Solution
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Observational
  5. Article
  6. Effects of anesthetics on development of gynecological cancer.Frontiers in cell and developmental biology · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Emma HasselgrenDepartment of Physiology and Pharmacology, Division of Anaesthesiology, Karolinska Institutet, Stockholm, Sweden, Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden. Electronic address: emma.hasselgren@regionstockholm.se.
Nina Groes-KofoedDepartment of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet, Stockholm, Sweden, Department of Pelvic Cancer, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.
Henrik FalconerDepartment of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet, Stockholm, Sweden, Department of Pelvic Cancer, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.
Håkan BjörneDepartment of Physiology and Pharmacology, Division of Anaesthesiology, Karolinska Institutet, Stockholm, Sweden, Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.
Diana ZachDepartment of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet, Stockholm, Sweden, Department of Pelvic Cancer, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.
Daniel HundeDepartment of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet, Stockholm, Sweden, Department of Pelvic Cancer, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.
Hemming JohanssonDepartment of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
Mihaela AspDepartment of Clinical Science, Division of Obstetrics and Gynaecology Lund University, Lund, Sweden, Department of Obstetrics and Gynaecology, Skåne University Hospital, Lund, Sweden.
Päivi KannistoDepartment of Clinical Science, Division of Obstetrics and Gynaecology Lund University, Lund, Sweden, Department of Obstetrics and Gynaecology, Skåne University Hospital, Lund, Sweden.
Anil GuptaDepartment of Physiology and Pharmacology, Division of Anaesthesiology, Karolinska Institutet, Stockholm, Sweden, Department of Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.
Sahar SalehiDepartment of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet, Stockholm, Sweden, Department of Pelvic Cancer, Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 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.

methodsA 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.

resultsOf 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.

conclusionIntraperitoneal local anaesthetic did not shorten the time to RIOT among women undergoing surgery for advanced ovarian cancer in this trial. CLINICAL

trial registrationClinicalTrials.gov (NCT04065009), European Union Clinical Trials Register (2019-003299-38/SE).

Indexed as

Anesthetics, LocalCytoreduction Surgical ProceduresOvarian NeoplasmsRopivacaineAdultAgedChemotherapy, AdjuvantDouble-Blind MethodFemaleHumansInjections, IntraperitonealMiddle AgedAnesthetics, LocalRopivacainecytoreductive surgeryintraperitoneallocal anaestheticovarian cancerreturn to intended oncologic therapyropivacainetime interval to chemotherapy

Identifiers

PMID39572271
PMCPMC11867074

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.