The IPLA-OVCA Trial, Intra-Peritoneal Local Anaesthetics in Ovarian Cancer (IPLA-OVCA)
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ClinicalTrials.gov Identifier: NCT04065009 |
Recruitment Status :
Recruiting
First Posted : August 22, 2019
Last Update Posted : June 24, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Advanced Ovarian Cancer | Drug: Ropivacaine Drug: Saline Solution | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomised, double blind, prospective, multicenter |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Study drugs are blinded and administered perioperatively. Fully blinded for all (participants, assessors etc) |
Primary Purpose: | Other |
Official Title: | 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 |
Actual Study Start Date : | August 26, 2020 |
Estimated Primary Completion Date : | December 26, 2023 |
Estimated Study Completion Date : | August 26, 2028 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Normal saline administered intraperitoneally at defined times during upfront surgery and intermittently postoperatively for 72 hours
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Drug: Saline Solution
Placebo will be administered intraperitoneally
Other Name: Normal saline |
Experimental: Experimental
Local anesthetic (ropivacaine) administered intraperitoneally at defined times during upfront surgery and intermittently postoperatively for 72 hours
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Drug: Ropivacaine
Experimental drug will be administered intraperitoneally
Other Name: Narop |
- Time-interval from upfront surgery to adjuvant chemotherapy [ Time Frame: Number of days to start of adjuvant chemotherapy (0 - 60 days) ]Days from surgery to first infusion of adjuvant chemotherapy
- Postoperative complications [ Time Frame: 30 days postoperatively ]Assessed according to the Clavien-Dindo Nomenclature
- Overall survival [ Time Frame: 3 and 5 years after surgery ]Death of any reason
- Postoperative quality of recovery [ Time Frame: Perioperatively ]As measured by validated instruments
- Postoperative morbidity [ Time Frame: Perioperatively ]As measured by validated instruments

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065009
Contact: Sahar Salehi, MD, PhD | 08-51770000 | sahar.salehi@sll.se | |
Contact: Emma Hasselgren, MD | 08-51770000 | emma.hasselgren@sll.se |
Sweden | |
Karolinska Hospital, Solna | Recruiting |
Stockholm, Sweden, 17176 | |
Contact: Katja Tobin Klinisk prövningsledare/Clinical Research Manager +46 8 517 745 15 katja.tobin@sll.se | |
Contact: Katja Wiklund Clinical Research Manager/Quality coordinator +46 8 517 725 84 katja.wiklund@sll.se |
Principal Investigator: | Sahar Salehi, MD, PhD | Karolinska Institute and Karolinska University Hospital |
Responsible Party: | Sahar Salehi, Senior Consultant, Assistant Professor, Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT04065009 |
Other Study ID Numbers: |
20190729 |
First Posted: | August 22, 2019 Key Record Dates |
Last Update Posted: | June 24, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | All study data will be retained at site of patient recruitment. Primary investigator and statistician will only have access to coded patient identity |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Local Anesthesia Time-interval from surgery to adjuvant chemotherapy advanced ovarian cancer |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Ropivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |