Study on Timing of Chemotherapy After Surgery with Ropivacaine and Sodium Chloride in Patients with Advanced Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying advanced epithelial ovarian cancer, which is a type of cancer that affects the ovaries and is in an advanced stage. The study is investigating the use of a treatment involving Ropivacaine Hydrochloride, a local anesthetic, administered directly into the abdominal cavity during and after surgery. The aim is to see if this treatment can help patients start their chemotherapy sooner after undergoing surgery to remove as much of the cancer as possible.

Participants in the study will receive either the local anesthetic or a placebo during their surgery and for up to 72 hours afterward. The study will monitor how quickly patients can begin their chemotherapy after surgery, as well as any complications or side effects they may experience. The study will also look at the overall recovery and survival of the patients.

The trial is designed to be double-blind, meaning neither the patients nor the doctors will know who is receiving the actual medication or the placebo. This helps ensure that the results are unbiased. The study will take place over several years, with the goal of improving treatment outcomes for women with advanced ovarian cancer.

1 joining the trial

Upon joining the trial, you will be required to provide a signed written informed consent. This confirms your understanding and agreement to participate in the study.

2 pre-surgery preparation

You will be scheduled for upfront cytoreductive surgery, which is a procedure aimed at removing as much of the ovarian cancer as possible. This is for patients with stage III or IV epithelial ovarian cancer.

3 administration of medication during surgery

During the surgery, a local anesthetic called ropivacaine hydrochloride will be administered intraperitoneally, which means it will be delivered directly into the abdominal cavity. The concentration used will be 0.2%.

4 post-surgery medication administration

After the surgery, ropivacaine hydrochloride will continue to be administered intermittently for up to 72 hours. This is to manage pain and potentially allow for an earlier start of chemotherapy.

5 monitoring and follow-up

You will be monitored for any postoperative complications, including cardiac and renal impairment. Your quality of recovery will also be assessed.

6 start of adjuvant chemotherapy

The primary goal of the trial is to determine the time it takes to start adjuvant chemotherapy after the cytoreductive surgery. This will be closely monitored and recorded.

7 end of trial participation

Your participation in the trial will conclude after the necessary data has been collected and analyzed. The estimated end date for the trial is December 31, 2028.

Who Can Join the Study?

Must be a woman over the age of 18.
Must have a health status classified as ASA I-III. This means the patient is in one of the following categories:
- ASA I: A normal healthy patient.
- ASA II: A patient with mild systemic disease.
- ASA III: A patient with severe systemic disease.
Must be scheduled for upfront cytoreductive surgery for stage III or IV epithelial ovarian cancer. This is a type of surgery aimed at removing as much of the cancer as possible.
Must have signed a written informed consent. This means the patient has agreed to participate in the study after being fully informed about the details and risks involved.

Who Cannot Join the Study?

Patients who do not have advanced epithelial ovarian cancer stage III-IV cannot participate.
Only female patients can participate; male patients are excluded.
Patients who are not in the specified age range cannot participate. (The specific age range is not provided here.)
Patients who are not undergoing cytoreductive surgery for their ovarian cancer cannot participate. (Cytoreductive surgery is a procedure to remove as much of the tumor as possible.)
Patients who are not able to start adjuvant chemotherapy after surgery cannot participate. (Adjuvant chemotherapy is additional cancer treatment given after the primary treatment to lower the risk of the cancer returning.)
Patients who are part of a vulnerable population may be excluded. (Vulnerable populations include groups like children, pregnant women, or those unable to consent for themselves.)

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Karolinska University Hospital	Solna	Sweden
Lund University Hospital	Lund	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	03.08.2020

Trial locations

Investigated drugs:

Ropivacaine is a local anesthetic used in this clinical trial. It is administered directly into the abdominal cavity during and after surgery for up to 72 hours. The purpose of using Ropivacaine in this way is to help manage pain after surgery for patients with advanced ovarian cancer. By reducing pain, it is hoped that patients can recover more quickly and start their chemotherapy treatment sooner. This approach aims to improve the overall treatment timeline and potentially enhance the effectiveness of the cancer therapy.

Investigated diseases:

Ovarian cancer

Advanced epithelial ovarian cancer stage III-IV – This is a type of cancer that originates in the epithelial cells lining the ovaries and has progressed to an advanced stage, specifically stages III and IV. In stage III, the cancer has spread beyond the pelvis to the lining of the abdomen or to the lymph nodes. By stage IV, the cancer has spread to distant organs such as the liver or lungs. The disease often begins with subtle symptoms, which can include abdominal bloating, pelvic pain, and changes in bowel habits. As it progresses, these symptoms may become more pronounced and persistent. The progression of the disease is marked by the spread of cancerous cells to other parts of the body, complicating treatment and management.

Trial ID:

2023-507732-20-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Timing of Chemotherapy After Surgery with Ropivacaine and Sodium Chloride in Patients with Advanced Ovarian Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?