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 study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Uwfmvwqranwl Mpweoxb Chdttev Gnauxdvow	Groningen	The Netherlands
Epwoooz Uxphehkqpttg Mkyvjvk Cwbecya Refxndjsl (ewyjruo Mmq	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.10.2024

Trial locations

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.

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 ID:

2024-510912-66-00

Protocol code:

ABR 85582.100.23

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?