Comparing Pain Relief Methods in Colorectal Cancer Surgery: TAP Block vs. Port Site Infiltration with Levobupivacaine for Patients in ERAS Program

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What is this study about?

This clinical trial is focused on patients with colorectal cancer, a type of cancer that affects the colon or rectum. The study is designed to compare two methods of pain relief for patients undergoing scheduled laparoscopic surgery, which is a minimally invasive surgical technique. The two methods being compared are the Transversus Abdominis Plane (TAP) Block and the infiltration of laparoscopic port site wounds with a local anesthetic called Levobupivacaine. Levobupivacaine is a medication used to numb a specific area of the body to prevent pain during and after surgery.

The purpose of the study is to determine which pain relief method is more effective in reducing postoperative pain. Participants will receive either the TAP Block or the wound infiltration with Levobupivacaine during their surgery. After the surgery, the level of pain will be assessed using a visual analog scale, which is a tool that helps measure pain intensity. Additionally, the study will monitor the use of pain medications such as minor opioids like tramadol and major opioids like morphine, as well as the occurrence of nausea and vomiting after the surgery.

The study will follow participants for a short period after their surgery to collect data on pain levels and any side effects. This information will help doctors understand which method provides better pain relief and improves recovery for patients with colorectal cancer undergoing laparoscopic surgery.

1 joining the study

Participation begins after meeting the inclusion criteria: being over 18 years old and scheduled for specific types of laparoscopic colorectal cancer surgery.

The study aims to compare two pain management techniques after surgery.

2 surgery preparation

Preparation for laparoscopic colorectal cancer surgery is conducted. This includes procedures like right hemicolectomy, left hemicolectomy, total colectomy, abdominoperineal resection of the rectum, or low/ultra-low anterior resection of the rectum.

3 pain management technique

Two techniques are compared: transversus abdominis plane (TAP) block and laparoscopic port site wound infiltration with levobupivacaine, a local anesthetic.

The method used will be determined as part of the study protocol.

4 postoperative pain assessment

Pain intensity is measured using the visual analog scale (VAS) at specific intervals: 2, 6, 24, and 48 hours after surgery.

5 opioid consumption monitoring

The amount of minor (tramadol) and major (morphine) opioids administered is recorded at the same intervals as the VAS measurements.

6 monitoring of side effects

The incidence of postoperative nausea and vomiting is monitored and recorded.

Who Can Join the Study?

Patients must be over 18 years old.
Patients must be scheduled for laparoscopic colorectal cancer surgery. This includes specific types of surgery such as:
- Right hemicolectomy
- Left hemicolectomy
- Total colectomy
- Abdominoperineal resection of the rectum
- Low or ultra-low anterior resection of the rectum
Both male and female patients can participate.
The study does not include vulnerable populations. This means groups that might need special protection, like children or people who cannot make decisions for themselves, are not part of this study.

Who Cannot Join the Study?

Patients who are not diagnosed with colorectal cancer cannot participate. Colorectal cancer is a type of cancer that affects the colon or rectum, which are parts of the large intestine.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot give consent or are unable to understand the study, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	02.09.2024

Trial locations

Investigated drugs:

Levobupivacaine

Transversus Abdominis Plane (TAP) Block is a pain relief technique used during and after surgery. It involves injecting a local anesthetic into the area between the internal oblique and transversus abdominis muscles of the abdomen. This helps to numb the nerves in the abdominal wall, reducing pain after surgery.

Laparoscopic Port Site Wound Infiltration is another method for managing pain after surgery. In this technique, a local anesthetic is injected directly into the surgical wound sites created by the laparoscopic instruments. This helps to numb the area and decrease pain following the procedure.

Investigated diseases:

Colorectal cancer

Colorectal cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. The progression of colorectal cancer can vary, but it often involves the growth of the tumor into the wall of the colon or rectum and potentially spreading to nearby lymph nodes or other organs. Symptoms may include changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss. Early stages may not present noticeable symptoms, making regular screenings important for detection.

Trial ID:

2024-514790-22-00

Protocol code:

TAPIL

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparing Pain Relief Methods in Colorectal Cancer Surgery: TAP Block vs. Port Site Infiltration with Levobupivacaine for Patients in ERAS Program

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?