Study on Pain Relief Using Serratus Plane Block with Ropivacaine, Lidocaine Hydrochloride, and Dexamethasone Sodium Phosphate for Intensive Care Patients Undergoing Pleural Drainage

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What is this study about?

This clinical trial is focused on evaluating pain management techniques during a procedure called pleural drainage, which is often performed in an intensive care unit. Pleural drainage is a medical procedure used to remove excess fluid or air from the space around the lungs. The study is particularly interested in comparing two methods of pain relief: a technique called the serratus plane block and local anesthesia. The serratus plane block is a type of regional anesthesia that involves injecting medication near the ribs to block pain in the chest area.

The medications being studied in this trial include DEXAMETHASONE SODIUM PHOSPHATE, ROPIVACAINE, and LIDOCAINE HYDROCHLORIDE. DEXAMETHASONE SODIUM PHOSPHATE is a corticosteroid used to reduce inflammation. ROPIVACAINE and LIDOCAINE HYDROCHLORIDE are local anesthetics, which means they are used to numb a specific area of the body to prevent pain during procedures. These medications are administered through injections, with ROPIVACAINE and LIDOCAINE HYDROCHLORIDE being used for local anesthesia, and DEXAMETHASONE SODIUM PHOSPHATE potentially being used to enhance the effects of the anesthetics.

The purpose of the study is to assess how effective the serratus plane block is compared to local anesthesia in managing acute pain during pleural drainage. Participants in the study will receive one of these pain management methods during their procedure. The study will monitor the intensity of pain experienced during and after the procedure, as well as any potential side effects or complications. The trial aims to provide valuable information on the best approach to pain management for patients undergoing pleural drainage in intensive care settings.

1 joining the study

Upon joining the study, eligibility is confirmed. This includes being 18 years or older, not intubated, and breathing on your own.

Consent is required, and you must be affiliated with a social security scheme.

You must be hospitalized in a multipurpose intensive care unit and require pleural drainage.

2 initial assessment

An initial assessment is conducted to evaluate your current health status and pain levels.

This involves measuring the intensity of acute pain using a numerical scale during pleural drainage.

3 medication administration

You will receive medications to manage pain during the procedure.

These include dexamethasone sodium phosphate administered intravenously, and ropivacaine and lidocaine hydrochloride administered through infiltration.

4 pleural drainage procedure

The pleural drainage procedure is performed in the intensive care unit.

Pain levels are monitored during the procedure using a numerical scale.

5 post-procedure monitoring

After the procedure, pain intensity is assessed at rest and during activities like forced inspiration and coughing over the first 24 hours.

Clinical tolerance is evaluated, including measurements of heart rate, respiratory rate, and oxygen saturation.

6 lung capacity assessment

Lung capacity is measured using a device called Voldyne at various intervals: 1 hour, 6 hours, and 24 hours after the procedure.

7 monitoring for complications

Monitoring for respiratory complications such as atelectasis and nosocomial pneumonia is conducted.

This involves clinical and radiological assessments.

8 rehabilitation and recovery

Early rehabilitation is encouraged, with attention to the time taken to first get up and engage in physiotherapy.

The duration of drainage and stay in the intensive care unit is recorded.

9 completion of study participation

Your participation in the study concludes after the necessary data is collected and analyzed.

The study is estimated to end by September 5, 2026.

Who Can Join the Study?

Patient must be 18 years or older.
Patient should not be intubated (meaning they are breathing on their own without a tube in their throat).
Patient must be breathing spontaneously (breathing naturally without assistance).
Patient must have signed a free and informed consent, which means they understand the study and agree to participate.
Patient must be affiliated with a social security scheme, meaning they have some form of health insurance or coverage.
Patient must be hospitalized in a multipurpose intensive care unit, which includes areas for surgical recovery, heart and lung care, or ongoing heart and lung treatment.
Patient must require pleural drainage, which is a procedure to remove gas or fluid from the space around the lungs.

Who Cannot Join the Study?

Patients who are not in the age range of 18 to 64 years old.
Patients who are not in the intensive care unit for anesthesia or intensive care reasons.
Patients who are part of a vulnerable population, which means they might have special needs or circumstances that require extra protection.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	07.09.2019

Trial locations

Investigated drugs:

Serratus Plane Block is a type of regional anesthesia used to numb the chest area. In this clinical trial, it is being evaluated for its effectiveness in managing acute pain during pleural drainage procedures in an intensive care unit. The block involves injecting an anesthetic near the serratus muscle, which can help reduce pain by blocking nerve signals in the chest area.

Local Anesthesia is a method used to numb a specific part of the body to prevent pain during medical procedures. In this trial, local anesthesia is used as a comparison to the serratus plane block to determine which method provides better pain relief during pleural drainage in patients in the intensive care unit.

Atelectasis – Atelectasis is a condition where part or all of a lung collapses or does not inflate properly, leading to reduced or absent gas exchange. It can occur when the tiny air sacs (alveoli) within the lung become deflated. This condition often results from a blockage of the air passages or pressure from outside the lung. Symptoms may include difficulty breathing, rapid breathing, and a feeling of tightness in the chest. It is commonly seen after surgery or in patients who are bedridden. The severity can vary, with some cases resolving on their own while others may require medical intervention.

Nosocomial Pneumonia – Nosocomial pneumonia, also known as hospital-acquired pneumonia, is an infection of the lungs that occurs during a hospital stay, typically 48 hours or more after admission. It is caused by bacteria, viruses, or fungi that are different from those causing community-acquired pneumonia. Patients may experience symptoms such as cough, fever, chills, and difficulty breathing. This type of pneumonia is often more severe than other forms due to the presence of antibiotic-resistant bacteria. It is a significant concern in healthcare settings, especially for patients with weakened immune systems or those on mechanical ventilation.

Trial ID:

2024-515722-83-00

NCT ID:

NCT03984656

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pain Relief Using Serratus Plane Block with Ropivacaine, Lidocaine Hydrochloride, and Dexamethasone Sodium Phosphate for Intensive Care Patients Undergoing Pleural Drainage

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?