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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

3 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

Morphine – Morphine is typically administered through injection or orally in tablet form. It is a well-established medication in medical literature, widely used for pain management. The main therapeutic indication for morphine is to relieve moderate to severe pain, often used in surgical settings. At the molecular level, morphine works by binding to opioid receptors in the brain and spinal cord, reducing the perception of pain. It is classified as an opioid analgesic.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507090-18-00Protocol codeTAP-INEstimated enrolment60 patientsSponsorHospital Universitario La Paz

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