Clinical trial · Interventional
The IPLA-OVCA Trial, Intra-Peritoneal Local Anaesthetics in Ovarian Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
Surgery and chemotherapy combined constitute first line treatment in women with advanced ovarian cancer. The aim of surgery apart from staging is cytoreduction, i.e. surgical resection of tumour. Radical resection of all tumour visible by the naked eye followed by adjuvant chemotherapy is associated with best chance of prolonged survival. However, because of tumour dissemination in the peritoneal cavity, radical surgery is often very extensive with surgery in all quadrants of the abdomen and multi-organ resection with substantial risk of postoperative severe complications and subsequent delay in administration of adjuvant chemotherapy. Longer time-interval between surgery to start of adjuvant chemotherapy has been associated with decrease in survival. Surgery presents opportunities not only for eradicating tumours but, paradoxically, also for proliferation and invasion of residual cancer cells. It increases the shedding of malignant cells into the blood and lymphatic circulations, inhibits their apoptosis and potentiates their invasion capacity. Additionally, the immune system, the inflammatory system and the neuroendocrine system react to surgery with important changes, which have been proven to promote progression of cancer. Several anaesthesia-related factors play an important role in perioperative tumorigenesis such as inhalational anaesthetics, opiate analgesics, local anaesthetics and regional anaesthesia, all of which may impact short-term morbidity and long-term mortality. A previous randomized placebo-controlled pilot study suggests that women who receive local anesthetics intraperitoneally preoperatively have a significantly decreased time-interval to initiation of adjuvant chemotherapy. In a prospective, randomised, multi-centre study, we plan to further assess if intraperitoneal local anaesthetics administered perioperatively during 72 h leads to early start of chemotherapy compared to placebo in patients undergoing cytoreductive surgery for FIGO stage III-IV ovarian cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ropivacaine | Drug | — | UNRESOLVED |
| Saline Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Normal saline administered intraperitoneally at defined times during upfront surgery and intermittently postoperatively for 72 hours
- interventionNames
- Drug: Saline Solution
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Local anesthetic (ropivacaine) administered intraperitoneally at defined times during upfront surgery and intermittently postoperatively for 72 hours
- interventionNames
- Drug: Ropivacaine
Primary outcomes (1)
- measure
- Time-interval from upfront surgery to adjuvant chemotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * ASA I-III * Scheduled for upfront cytoreductive surgery for presumed stage III or IV epithelial ovarian cancer * Signed written informed consent Exclusion Criteria: * Contraindication to epidural anesthesia * Allergy to any component drugs used during epidural or intraperitoneal anesthesia (Ropivacaine, Sufentanil) * Uncontrolled renal, liver, heart failure or ischemic heart disease * Speech, language or cognitive difficulties * Women in whom cytoreductive surgery is not attempted at time of upfront laparotomy due to extent of disease
References
Publications (5)
- BACKGROUNDHayden JM, Oras J, Block L, Thorn SE, Palmqvist C, Salehi S, Nordstrom JL, Gupta A. Intraperitoneal ropivacaine reduces time interval to initiation of chemotherapy after surgery for advanced ovarian cancer: randomised controlled double-blind pilot study. Br J Anaesth. 2020 May;124(5):562-570. doi: 10.1016/j.bja.2020.01.026. Epub 2020 Mar 13. PMID 32172954
- DERIVEDHasselgren E, Kofoed NG, Falconer H, Bjorne H, Zach D, Hunde D, Johansson H, Asp M, Thorlacius K, Kannisto P, Salehi S. Prospective Assessment of Clinically Relevant Fluid Balance Thresholds Associated With Postoperative Complications in Advanced Ovarian Cancer. Acta Anaesthesiol Scand. 2025 Oct;69(9):e70112. doi: 10.1111/aas.70112. PMID 40856042
- DERIVEDNunez-Rodriguez E, Zhang H, Sah D, Cata JP. Intersection Between Local Anesthetics and Cancer Biology: What Now? Where Are We Going? Adv Biol (Weinh). 2025 Oct;9(10):e00122. doi: 10.1002/adbi.202500122. Epub 2025 Aug 7. PMID 40772525
- DERIVEDGultekin O, Gonzalez-Molina J, Sarhan D, Groes-Kofoed N, Hassan MU, Lehti K, Salehi S. Systemic and tumor-specific inflammatory markers VCAM-1 and ICAM-1 as indicators of extent of surgery and oncologic outcome in advanced ovarian cancer. Transl Oncol. 2025 Sep;59:102462. doi: 10.1016/j.tranon.2025.102462. Epub 2025 Jul 12. PMID 40652770
- DERIVEDHasselgren E, Groes-Kofoed N, Falconer H, Bjorne H, Zach D, Hunde D, Johansson H, Asp M, Kannisto P, Gupta A, Salehi S. 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. 2025 Mar;134(3):662-670. doi: 10.1016/j.bja.2024.10.015. Epub 2024 Nov 20. PMID 39572271