Study of Recovery After Surgery for Colorectal Cancer Using Lidocaine and Ropivacaine in Patients Undergoing Laparoscopic Colorectal Cancer Surgery

3 1 1 1

What is this study about?

This study involves patients who are having scheduled surgery to remove part of the colon or rectum due to colorectal cancer using a laparoscopic approach, which means the surgery is done through small incisions using a camera and specialized instruments. The study will use two different pain relief medications during and after the surgery: lidocaine, which will be given through a vein during the operation, and ropivacaine, which will be injected into the areas where the surgical instruments are inserted. In addition to these two main medications, patients may receive other medications commonly used during and after surgery to manage pain and support recovery, including nefopam, dexamethasone, paracetamol, sufentanil, parecoxib, celecoxib, morphine sulfate, propofol, and ketamine.

The purpose of this study is to evaluate how well the combination of intravenous lidocaine and ropivacaine infiltration at the surgical sites helps patients recover after their colorectal surgery. Recovery will be measured using a questionnaire called the QOR-15, which assesses how well patients are doing twenty-four hours after their operation. The study will also examine whether these medications reach levels in the blood that could cause unwanted effects, and will look for any signs of medication-related problems in the first two hours after surgery. Pain levels will be measured at different times using a numbering system where patients rate their pain, both when resting and when moving.

During the study, patients will be monitored for various aspects of their recovery over a period that extends to three months after surgery. This includes tracking how much pain medication they need, when their digestive system starts working normally again, whether they experience any unusual sensations around the surgical area, and whether they develop any nerve-related pain. The study will also record any medical or surgical complications that occur, whether patients are able to start chemotherapy if needed within two months after surgery, how long patients stay in the hospital, and how satisfied patients are with their care when they leave the hospital. Blood samples will be taken to measure the levels of lidocaine and ropivacaine in the bloodstream.

1 Anesthesia and surgery preparation

Your scheduled surgery will be performed using a minimally invasive technique called laparoscopic surgery for colorectal cancer. This means small incisions will be made in your abdomen through which surgical instruments are inserted.

Before the surgery begins, you will receive anesthesia to ensure you are asleep and pain-free during the procedure. The anesthesia will include propofol administered through a vein as an injection or infusion, and ketamine given through a vein at a dose of 10 mg per milliliter.

During the operation, you will receive sufentanil at a dose of 5 micrograms per milliliter through a vein to manage pain.

2 Pain management during surgery

During the surgery, you will receive lidocaine administered through a vein. This medication helps reduce pain and improve recovery after surgery.

The surgical sites where the instruments are inserted will be treated with ropivacaine at a concentration of 2 mg per milliliter. This local anesthetic is injected into the tissue to provide pain relief at the incision sites.

You will also receive dexamethasone phosphate at a dose of 8 mg through a vein. This medication helps reduce inflammation and nausea after surgery.

3 Immediate post-surgery monitoring

After the surgery is completed, you will be moved to a recovery area where you will be monitored for up to two hours.

During this time, medical staff will observe you for any signs of medication-related side effects, including heart rhythm changes, tingling around the mouth, headaches, visual or hearing changes, tremors, or other neurological symptoms.

Blood samples will be taken to measure the levels of lidocaine and ropivacaine in your blood to ensure they remain within safe limits.

4 Pain assessment at two hours after surgery

At two hours after your surgery, your pain level will be assessed while you are resting. You will be asked to rate your pain on a scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.

5 Pain management in the first 48 hours

You will receive paracetamol through a vein at a dose of 10 mg per milliliter to help control pain.

You will also receive nefopam at a dose of 20 mg through a vein as needed for pain relief.

If additional pain relief is needed, you will receive parecoxib at a dose of 40 mg through a vein.

For oral pain management, you may receive celecoxib capsules at a dose of 100 mg.

If stronger pain relief is required, you will receive morphine sulfate capsules at a dose of 5 mg. The total amount of morphine-type medications you receive will be recorded and converted to a standard measurement for comparison.

6 Assessment at 24 hours after surgery

At 24 hours after your surgery, your overall recovery will be assessed using a questionnaire called the QOR-15. This questionnaire asks about your physical comfort, emotional state, and ability to perform daily activities.

Your pain level will be assessed again at rest and while moving. You will be asked to rate your pain on the same 0 to 10 scale.

7 Assessment at 48 hours after surgery

At 48 hours after your surgery, your pain level will be assessed once more, both at rest and while moving.

You will be asked about the maximum pain you experienced during the first 48 hours after surgery.

Medical staff will check for any unusual sensations around your surgical scars, such as increased sensitivity to pain, sensitivity to touch that normally would not be painful, or numbness.

You will be asked questions to determine if you are experiencing any nerve-related pain. This assessment uses a scoring system where a score greater than 4 out of 10 indicates nerve pain.

The medical team will ask you daily about your bowel function, including whether you have passed gas or had a bowel movement, and whether you are able to tolerate food.

8 Hospital discharge

The length of your hospital stay will be recorded from the day you are admitted until the day you are discharged.

Before you leave the hospital, you will be asked to complete a satisfaction questionnaire called the EVANS score to evaluate your experience.

9 Follow-up at one month after surgery

At one month after your surgery, any medical or surgical complications you may have experienced will be assessed using a classification system called the Clavien Dindo score. This system categorizes complications based on their severity.

10 Follow-up at two months after surgery

At two months after your surgery, the medical team will determine whether you are able to begin chemotherapy treatment if it has been recommended by your cancer care team.

11 Follow-up at three months after surgery

At three months after your surgery, you will be assessed again for nerve-related pain using the same scoring system as before. A score greater than 4 out of 10 indicates nerve pain.

Who Can Join the Study?

  • You must be scheduled to have laparoscopic colorectal cancer surgery, which is a type of surgery for cancer in the colon or rectum performed through small cuts in the abdomen using a special camera and instruments
  • You must be 18 years of age or older
  • If you are a woman who can become pregnant, you must use a highly effective method of birth control, such as birth control pills, patches, vaginal rings, injections, implants, intrauterine devices, having your tubes tied, having a partner with a vasectomy, or not having sexual intercourse
  • You must understand the study information and sign a document showing you agree to participate, which is called informed consent
  • You must be enrolled in a Social Security plan

Who Cannot Join the Study?

  • The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in this study
  • Without detailed exclusion criteria listed in the trial information, it is not possible to identify which medical conditions, medications, or other factors would prevent someone from joining this study
  • Generally, clinical trials have exclusion criteria to ensure patient safety and reliable results, but these specific details are not available in the provided information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Amiens Picardie Amiens France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.10.2025

Trial locations

Lidocaine is a medication that blocks pain signals. In this study, it will be given through a vein (intravenously) to help reduce pain and improve recovery after surgery.

Ropivacaine is a local anesthetic medication that numbs a specific area of the body. In this study, it will be injected into the sites where surgical instruments were inserted during the laparoscopic surgery to help control pain after the operation.

Investigated diseases:

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, which are parts of the large intestine in the digestive system. The disease typically starts as small growths called polyps on the inner lining of the colon or rectum that can develop into cancer over time. As the cancer grows, it can spread through the layers of the intestinal wall. The disease may cause changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss. In early stages, colorectal cancer may not cause any noticeable symptoms. Without intervention, the cancer can spread to nearby lymph nodes and other organs in the body.

Trial ID:
2025-523207-29-00
Protocol code:
PI2025_843_0004
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study of belzutifan and lenvatinib for patients with von Hippel-Lindau disease-associated tumors or other specific solid tumors.

    Recruiting

    3 1 1
    Investigated drugs:
    Belgium Czechia Denmark Finland France Germany +4
  • A study to evaluate the use of [68Ga]BED003 for imaging colorectal, gastric, pancreatic, breast, and ovarian cancers.

    Recruiting

    2 1 1
    Investigated diseases:
    Italy The Netherlands