The IPLA-OVCA Trial, Intra-Peritoneal Local Anaesthetics in Ovarian Cancer

• Status: Recruiting
• Trial end date: 2028-08-26
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; Skane University Hospital
• Treatments: Anesthetics; Anesthetics, Local; Ropivacaine

Criteria

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