NCT03984656 Evaluation of the Analgesia by Serratus Plane Block During Pleural Drainage in Intensive Care Unit.
| NCT ID | NCT03984656 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Analgesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2019-06-04 |
| Primary Completion | 2026-09-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 70 participants in total. It began in 2019-06-04 with a primary completion date of 2026-09-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pleural drainage under local anesthesia is a frequent practice in resuscitation, experienced as an unpleasant and painful event for patients. Pain management is an important issue for early rehabilitation, decrease hospitalisation's cost and shortening the length of stay in intensive care unit (ICU). A new type of locoregional anesthesia called Serratus plane block described by Blanco in 2013 showed a benefit in per and postoperative analgesia in thoracic surgery and carcinologic breast surgery, allowing a decrease in morphine use and an improvement of the patient's general satisfaction. Serratus plane block is a very effective technique in chest wall analgesia, easy and safe to perform, with few complications. No studies to date have evaluated this anesthetic practice in intensive care for pleural drainage. This technique could be used outside the operating room to improve the intensive care patients, who often have heavier pathologies and greater pain, such as patients with chest trauma or patients with cardiac or respiratory disease. The investigators would like to conduct a preliminary study of superiority in the CHU Amiens intensive care unit, to study the interest of the Serratus plane block in comparison with local anesthesia on the management of acute pain during pleural drainage.
Eligibility Criteria
Inclusion Criteria: * patients over 18 years old. * non-intubated patient with spontaneous ventilation * free and informed consent of the patient, * affiliated to a social security scheme * hospitalized in ICU unit including surgical ICU, cardiothoracic and respiratory ICU or cardiothoracic and respiratory continuous care unit. * requiring pleural drainage gas or fluid * conscious patient, not sedated. Exclusion Criteria: * patient under the age of 18 years old. * patient refusal * under curatorship or deprivation of liberty * pregnant, parturient or breastfeeding woman * contraindication to Lidocaine or Ropivacaine * coagulation disorders
Contact & Investigator
Louise Badoux, MD
PRINCIPAL INVESTIGATOR
CHU amiens
Frequently Asked Questions
Who can join the NCT03984656 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Analgesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03984656 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 70 participants.
Is NCT03984656 currently recruiting?
Yes, NCT03984656 is actively recruiting participants. Contact the research team at badoux.louise@chu-amiens.fr for enrollment information.
Where is the NCT03984656 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT03984656 clinical trial?
NCT03984656 is sponsored by Centre Hospitalier Universitaire, Amiens. The principal investigator is Louise Badoux, MD at CHU amiens. The trial plans to enroll 70 participants.