Evaluation of Intraperitoneal Ropivacaine Hydrochloride on Chemotherapy Timing Post-Cytoreductive Surgery in Advanced Epithelial Ovarian Cancer

The primary objective of this study is to investigate whether **Ropivacaine 0.2%** administered intraperitoneally during surgery and intermittently thereafter for up to 72 hours in patients with stage III-IV advanced epithelial ovarian cancer undergoing cytoreductive surgery leads to an earlier start of adjuvant chemotherapy. This is clinically relevant as reducing the time interval between surgery and chemotherapy initiation may improve treatment outcomes and enhance patient prognosis.

Secondary objectives include evaluating postoperative complications and morbidity, assessing the quality of recovery, and determining overall survival. These factors are crucial for understanding the broader impact of the treatment regimen on patient health and recovery trajectory.

The clinical trial involves **women** over the age of 18 diagnosed with **advanced epithelial ovarian cancer stage III-IV**. The study population is exclusively female, with participants scheduled for upfront cytoreductive surgery. The trial does not include male subjects. Participants are required to be classified as ASA I-III, indicating a range from normal healthy patients to those with mild systemic disease. The trial population was selected based on their scheduled surgery and the signing of a written informed consent. The sponsor has not provided the total number of participants. The study does not specify any particular lifestyle considerations such as diet or physical activity. The trial includes a vulnerable population, as indicated by the selection criteria. The sponsor has not disclosed further details regarding the selection process or additional demographic information.

The clinical trial is designed as a **randomized**, **double-blind**, multicenter study to evaluate the time interval between cytoreductive surgery and the initiation of adjuvant chemotherapy in patients with advanced epithelial ovarian cancer, specifically stages III-IV. The primary objective is to determine if the administration of **ropivacaine hydrochloride** 0.2% intraperitoneally during surgery and intermittently for up to 72 hours postoperatively can lead to an earlier start of adjuvant chemotherapy. The trial will involve the use of **sodium chloride** as a placebo control. The study is expected to run from August 3, 2020, to December 31, 2028.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age over 18 years, ASA classification I-III, and scheduled upfront cytoreductive surgery for stage III or IV epithelial ovarian cancer. Informed consent must be obtained. Following the screening, participants will be randomized to receive either the active treatment or placebo. The study will include follow-up visits to monitor postoperative complications, morbidity, quality of recovery, and any cardiac or renal impairments. The primary endpoint is the time to start adjuvant chemotherapy, while secondary endpoints include overall survival and other postoperative outcomes.

The expected duration of participant involvement is up to 72 hours post-surgery, with the possibility of early termination if significant adverse events occur or if the participant withdraws consent. The trial is categorized as a Phase III study, indicating its advanced stage in the clinical research process. The study's design ensures rigorous control and blinding to maintain the integrity of the results, with the ultimate goal of improving treatment timelines and outcomes for patients with advanced epithelial ovarian cancer.

The clinical trial involves the administration of **Ropivacaine Hydrochloride**, an experimental medication, in the form of an infusion. The active substance, **Ropivacaine Hydrochloride**, is of chemical origin. The pharmaceutical form is specifically designed for **intraperitoneal use**. The dosing regimen includes a maximum daily dose of 320 mg, with a total maximum dose of 960 mg over a treatment period of up to 3 days. The administration is intended to be intermittent, occurring during surgery and continuing for up to 72 hours postoperatively. This treatment is being evaluated for its potential to facilitate an earlier start of adjuvant chemotherapy in patients with stage III-IV epithelial ovarian cancer undergoing cytoreductive surgery.

In addition to the experimental treatment, **Sodium Chloride** is used as a non-experimental treatment in the study, serving as a placebo. It is also administered as a solution for infusion via the **intraperitoneal route**. The dosing schedule for Sodium Chloride mirrors that of Ropivacaine Hydrochloride, with a maximum daily dose of 320 mg and a total maximum dose of 960 mg over a 3-day period. The use of Sodium Chloride as a placebo allows for the assessment of the efficacy and safety of Ropivacaine Hydrochloride by providing a comparator treatment within the trial.

Efficacy in this clinical trial will be assessed primarily by measuring the time in days to the start of adjuvant chemotherapy following **cytoreductive surgery** in patients with stage III-IV epithelial ovarian cancer. This primary endpoint aims to determine whether the administration of Ropivacaine 0.2% intraperitoneally during surgery and intermittently for up to 72 hours post-surgery facilitates an earlier initiation of adjuvant chemotherapy.

Secondary endpoints will include the evaluation of postoperative complications, postoperative morbidity, quality of recovery, cardiac and renal impairment, and overall survival. These parameters will provide a comprehensive assessment of the treatment's impact on patient outcomes beyond the primary endpoint. The collection and analysis of these efficacy parameters will be conducted at specified intervals throughout the trial duration, ensuring a robust evaluation of the treatment's effectiveness.