Study on Pain Relief Using Levobupivacaine Hydrochloride for Patients Undergoing Laparoscopic Colorectal Surgery

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What is this study about?

This clinical trial is focused on patients who are scheduled to undergo laparoscopic colorectal surgery, which is a minimally invasive procedure used to treat conditions affecting the colon and rectum. The study aims to evaluate the effectiveness of two different pain management techniques used during and after surgery. One method involves wound infiltration, where a pain-relieving medication is directly applied to the surgical site. The other method is an ultrasound-guided transversus abdominis plane block, a technique where pain relief is provided by injecting medication near the nerves of the abdominal wall using ultrasound guidance.

The medication used in this study is called Levobupivacaine hydrochloride, which is a local anesthetic that helps numb the area to reduce pain. Participants in the study will be divided into two groups, with one group receiving the wound infiltration method and the other receiving the transversus abdominis plane block. The purpose of the study is to compare the total amount of opioid pain medication needed by each group within 48 hours after surgery, expressed in terms of morphine milligram equivalent.

Throughout the study, researchers will also observe and compare other factors such as pain levels at rest and during movement, the occurrence of nausea and vomiting, and the time it takes for patients to start eating, moving around, and being discharged from the hospital. The study will help determine which pain management technique is more effective in reducing the need for additional pain medication and improving recovery after laparoscopic colorectal surgery.

1 joining the study

Participation begins after signing the informed consent form, confirming understanding and agreement to the study terms.

Eligibility includes being scheduled for laparoscopic colorectal surgery, being over 18 years old, and having an ASA physical status classification of 1 to 3.

2 pre-surgery preparation

Preparation involves monitoring with a device called NOL, which helps assess pain levels during surgery.

No specific medications are administered at this stage.

3 surgery and pain management

During surgery, pain management is provided through either wound infiltration or an ultrasound-guided transversus abdominis plane (TAP) block.

The medication used is levobupivacaine hydrochloride, administered as a solution for injection or infusion.

4 post-surgery recovery

After surgery, pain levels and opioid consumption are monitored in the post-anesthesia recovery unit (PACU) and at 24 and 48 hours post-surgery.

Pain is assessed using a visual analog scale (VAS) or numerical rating scale (NRS).

5 monitoring and evaluation

The study evaluates differences in total opioid consumption between the TAP block and wound infiltration groups at 48 hours after surgery.

Secondary evaluations include pain scores at rest and movement, incidence of nausea and vomiting, and the onset of oral tolerance and ambulation.

6 end of participation

Participation concludes after the final assessments at 48 hours post-surgery.

The study aims to complete by October 1, 2025.

Who Can Join the Study?

Patients must be scheduled for laparoscopic colorectal surgery. This includes surgeries like right or left hemicolectomy, extended hemicolectomy, high anterior resection, total colectomy, or sigmoidectomy. Laparoscopic surgery is a type of surgery done through small cuts in the belly using a camera.
Patients must be older than 18 years.
Patients must have completed an informed consent. This means they agree to participate in the study by signing a document that explains the study and its risks.
Patients must be classified as ASA 1-3. This is a system used by doctors to describe a patient’s health status before surgery, where ASA 1 means healthy, ASA 2 means mild health issues, and ASA 3 means more severe health issues.
Patients must be willing to use a NOL monitor. This is a device used to measure pain levels during surgery.

Who Cannot Join the Study?

Patients who are not scheduled for laparoscopic colorectal surgery. This is a type of surgery done through small cuts in the belly to treat problems in the colon or rectum.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means groups of people who might need special protection or care.

Where you can join this trial?

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Site Name	City	Country	Status
Fpoxvyitj Pcgo Lc Iohisuxjrgenh Bidwuhvfj Dvi Hzzvcqiw Uizciyyrkxxgk Ly Psb	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.10.2023

Trial locations

Wound Infiltration is a technique used in this trial where a local anesthetic is directly injected into the surgical wound area. This method aims to reduce pain by numbing the specific area where surgery is performed, potentially decreasing the need for additional pain medications after the procedure.

Ultrasound-Guided Transversus Abdominis Plane Block is another pain management technique being studied. In this method, a local anesthetic is injected into the abdominal wall using ultrasound guidance to ensure accurate placement. This block targets nerves that supply the abdominal area, aiming to provide effective pain relief after surgery and reduce the need for opioids.

Laparoscopic Colorectal Surgery – This is a minimally invasive surgical procedure used to treat conditions affecting the colon and rectum. During the surgery, small incisions are made in the abdomen, and a camera along with specialized instruments are used to perform the operation. The procedure is often chosen for its benefits, such as reduced pain and quicker recovery compared to traditional open surgery. Patients undergoing this surgery may experience postoperative pain, which is managed through various pain relief methods. The focus of studies often includes evaluating different pain management techniques to optimize recovery.

Trial ID:

2023-507090-18-00

Protocol code:

TAP-IN

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pain Relief Using Levobupivacaine Hydrochloride for Patients Undergoing Laparoscopic Colorectal Surgery

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