Status:
COMPLETED
Sublingual Sufentanil PCA Usability for Postoperative Pain (Zalviso® System)
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Trauma
Surgery
Eligibility:
All Genders
18+ years
Brief Summary
Intravenous patient-controlled analgesia (iv-PCA) is the gold standard for the treatment of moderate to severe postoperative pain. It is used in more than 20% of cases after major surgery. Well known ...
Eligibility Criteria
Inclusion
- Adults
- 16 \<BMI \<40
- ASA I and II
- Patient with traumatic functional surgery - Knee and hip arthroplasty, shoulder surgery, tibial osteotomy / femoral osteotomy; or plastic and aesthetic surgery with volume correction of more than 30% of body surface area (bodylift), DIEP, DLA.
- Patient who should theoretically benefit of a postop self-controlled analgesia of morphine for 72 hours on average
- Patient informed of the modalities of the study with delivery of an information leaflet
- Free and informed consent collection
Exclusion
- Patient refusing to participate in the study
- Language barrier
- Hypersensitivity to sufentanil,
- Respiratory failure
- Renal insufficiency (GFR \<30 ml / min)
- Epilepsy not controlled by treatment
- Psychic and mental illness not controlled by treatment
- Hepatocellular insufficiency (TP \<50%)
- Heart failure (LVEF \<50%)
- patients with chronic pain, treated with level 3 analgesic and / or already treated for neuropathic pain
- Drug-addicted patients
- Pregnant or lactating women
Key Trial Info
Start Date :
June 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 24 2019
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03373851
Start Date
June 25 2018
End Date
May 24 2019
Last Update
September 2 2022
Active Locations (1)
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1
Hôpital de la Croix Rousse - Service d'Anesthésie-Réanimation
Lyon, France, 69004