ROPIVACAINE for Anesthesia | Intensive care

Stratification factors

• Baseline pain (EN) category (1-3, 4-6, 7-10)
• Care unit/service

Inclusion criteria

• {"criterion_text":"- Patient aged 18 or over, not intubated, spontaneously ventilating."}
• {"criterion_text":"- Free and informed consent signed."}
• {"criterion_text":"- Affiliate to a social security scheme."}
• {"criterion_text":"- Hospitalized in multipurpose intensive care unit including surgical resuscitation, cardiothoracic and respiratory resuscitation or continuing cardiothoracic and respiratory care services."}
• {"criterion_text":"- Requiring gas or fluid pleural drainage."}

Exclusion criteria

• {"criterion_text":"- Patient didn't agree to participate in the trial."}
• {"criterion_text":"- Patient under guardianship or curatorship or deprived of liberty."}
• {"criterion_text":"- Pregnant, parturient or breastfeeding woman."}
• {"criterion_text":"- Allergy and contraindication to Lidocaine or Ropivacaine."}
• {"criterion_text":"- Coagulation disorders."}

Primary endpoints

• {"endpoint_text":"- Intensity of acute pain during pleural drainage (H0) by numerical scale (EN).","definition_or_measurement_approach":"Measured at H0 using a numerical scale (EN) during pleural drainage."}

Secondary endpoints

• {"endpoint_text":"- Intensity of acute pain by EN at rest and during exercise (forced inspiration) at the end of pleural drainage (H0).","definition_or_measurement_approach":"Measured at H0 using numerical scale (EN) at rest and during forced inspiration."}
• {"endpoint_text":"- Intensity of acute pain from EN at rest and during exercise (cough and forced inspiration) after drainage over the first 24 hours (H0, H1, H6, H24).","definition_or_measurement_approach":"Measured using EN at timepoints H0, H1, H6, H24 at rest and during cough and forced inspiration."}
• {"endpoint_text":"- Clinical tolerance at the end of drainage (H0): MAP HR, FR, SpO2.","definition_or_measurement_approach":"Clinical parameters measured at H0: mean arterial pressure (MAP), heart rate (HR), respiratory rate (FR), SpO2."}
• {"endpoint_text":"- Lung capacity in milliliters measured by the Voldyne (maximum inspired volume) H1, H6, H24.","definition_or_measurement_approach":"Maximum inspired volume measured by Voldyne at H1, H6, H24."}
• {"endpoint_text":"- Respiratory complications: - atelectasis = auscultation + radiography or ultrasound - nosocomial pneumonia = 3 clinicoradiological criteria compatible with radiological infiltrate + hyperthermia (>38 or <36°C) or leukocytes (>12000 or <4000 GB/mm3) + purulent aspirations or suggestive auscultation or hypoxemia.","definition_or_measurement_approach":"Respiratory complications defined as: atelectasis by auscultation plus radiography/ultrasound; nosocomial pneumonia defined by 3 clinicoradiological criteria plus hyperthermia or leukocyte criteria and purulent aspirations or evocative auscultation or hypoxemia."}
• {"endpoint_text":"- Use of tracheal intubation.","definition_or_measurement_approach":"Occurrence of tracheal intubation during follow-up."}
• {"endpoint_text":"- Early rehabilitation: time to first getting up, physiotherapy.","definition_or_measurement_approach":"Time to first ambulation and initiation of physiotherapy."}
• {"endpoint_text":"- Duration of drainage.","definition_or_measurement_approach":"Measured duration of pleural drainage."}
• {"endpoint_text":"- Duration of stay in intensive care.","definition_or_measurement_approach":"Length of ICU stay."}
• {"endpoint_text":"- Duration of installation of anesthesia.","definition_or_measurement_approach":"Time required to install anesthesia."}

France

Earliest CTIS Part Ii Submission Date

10-07-2024

Latest Decision Or Authorization Date

30-07-2024

Processing Time Days

20

Number Of Sites

1

Number Of Participants

70

Primary sponsor

Full Name

Centre Hospitalier Universitaire Amiens Picardie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France