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Study on Levobupivacaine, Paracetamol, and Diclofenac for Pain Relief After Esophageal Lesion Procedure in Patients with Precancerous Esophageal Lesions

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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 studying pain relief after a procedure called *Endoscopic Submucosal Dissection* (ESD), which is used to treat *esophageal lesions*. These lesions can be *precancerous* or cancerous. The study will use a medication called *Levobupivacaine*, which is a type of local anesthetic, to see if it can help reduce pain immediately after the procedure. The main goal is to evaluate how effective *Levobupivacaine* is in providing pain relief within 90 minutes after the ESD.

Participants in the study will receive either *Levobupivacaine* or a placebo during their ESD procedure. The study will monitor pain levels at several intervals: within 90 minutes, 6 hours after the procedure, and daily for up to 14 days. The study will also track the overall use of pain relief medications during this period. Additionally, the study will observe any side effects related to the use of *Levobupivacaine*, including allergic reactions, and will record the length of hospital stay.

Other medications involved in the study include *Paracetamol* and *Diclofenac Sodium*, which are commonly used for pain relief. These medications may be used alongside *Levobupivacaine* to manage pain. The study aims to provide a better understanding of how effective *Levobupivacaine* is in managing pain after ESD and to ensure the safety of its use in this context.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age and the presence of a visible esophageal lesion.

    Informed consent is required to participate in the trial.

  2. Step 2

    Preparation for the procedure

    The patient is scheduled for an endoscopic submucosal dissection (ESD) to address esophageal lesions.

    Preparation for the procedure includes standard pre-operative protocols.

  3. Step 3

    Administration of medications

    During the procedure, a local injection of levobupivacaine is administered to provide pain relief.

    The medication is given as a solution for injection or infusion.

  4. Step 4

    Post-procedure monitoring

    Pain levels are assessed using a numerical rating scale (NRS) from 0 to 10 at 30, 60, and 90 minutes after the procedure.

    The primary goal is to evaluate the effectiveness of levobupivacaine in reducing major pain, defined as a score of four or higher.

  5. Step 5

    Ongoing pain assessment

    Pain scores are recorded within 90 minutes, 6 hours after the procedure, and daily up to 14 days.

    Patients maintain a diary to track pain levels and the use of pain relief medications.

  6. Step 6

    Monitoring for adverse events

    The incidence of any adverse events related to levobupivacaine, including allergic reactions, is monitored.

    Serious adverse events are also tracked throughout the study.

  7. Step 7

    Completion of the study

    The study concludes with an evaluation of cumulative pain over 14 days and the duration of pain until scores reach zero.

    The length of hospital stay is recorded as part of the study outcomes.

Who can join the trial?

4 criteria

  • Patients must be **18 years or older** at the time they agree to participate.
  • There must be a **visible lesion** in the esophagus, which is the tube that carries food from the mouth to the stomach. The lesion should be at least **20 mm in diameter**.
  • Patients should be **scheduled for esophageal ESD**, which is a procedure to remove certain types of growths or lesions from the esophagus.
  • Patients must provide **informed consent**, meaning they understand the study and agree to participate.

Who cannot join the trial?

1 criterion

  • Patients with **visible esophageal lesions**. These are areas in the esophagus that may be damaged or have abnormal growths, which could be cancerous or precancerous.
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Investigated drugs

Levobupivacaine is a medication used in this trial to provide pain relief after a procedure called Endoscopic Submucosal Dissection (ESD) for esophageal lesions. It is administered locally, meaning it is injected directly into the area where the procedure is performed. The goal is to reduce pain immediately after the procedure, specifically within the first 90 minutes.

What is already known about the treatment

Levobupivacaine – Levobupivacaine is administered as a local injection, typically used during procedures like endoscopic submucosal dissection (ESD) for esophageal lesions. It is currently being studied in clinical trials to assess its effectiveness in providing immediate pain relief after such procedures. The main therapeutic indication for levobupivacaine in this context is to alleviate pain following the treatment of visible esophageal lesions, which may be precancerous or cancerous. At the molecular level, levobupivacaine works by blocking sodium channels in nerve cells, which prevents the transmission of pain signals. It is classified pharmacologically as a local anesthetic.

Investigated diseases

Visible esophageal lesions (precancerous) – These are abnormal changes in the cells lining the esophagus that can be seen during an endoscopic examination. They are considered precancerous because they have the potential to develop into esophageal cancer if left untreated. The progression of these lesions can vary, with some remaining stable for years while others may progress to cancer. Factors such as chronic acid reflux, smoking, and alcohol consumption can contribute to their development. Regular monitoring and medical evaluation are important to assess any changes in the lesions over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510912-66-00Protocol codeABR 85582.100.23Estimated enrolment88 patientsSponsorSint Antonius Ziekenhuis Stichting

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