Sublingual Sufentanil PCA Usability for Postoperative Pain (Zalviso® System)

Completed

• Conditions: Trauma; Surgery
• Interventions: Device: Zalviso Device

• Registration Number: NCT03373851
• Lead Sponsor: Hospices Civils de Lyon

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 disadvantages of this method include the need of intravenous line (invasive, infection risk), the risk of pump programming error, possible delay for ambulation/barrier for enhanced rehabilitation programmes, and time/resource demanding (the need of preparation and installation). Sublingual sufentanil based PCA (Zalviso®) addresses cited issues. The safety and analgesia efficiency of this system is well described. However, the usability and satisfaction of Zalviso® varies depending on clinical settings. The goal of this study is to evaluate the usability and satisfaction of patients, nurses, and physical therapists using Zalviso® System during the first 72 hours in the settings of Enhanced Recovery After Surgery protocol after major interventions associated with moderate to severe postoperative pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-14
• Study Start: 2018-06-25
• Primary Completion: 2019-05-24
• Study Completion: 2019-05-24
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Zalviso	Zalviso Device	Patient willing to participate to the study, and scheduled for major functional surgery (arthroplasty, valgisation osteotomy, DIEP flap surgery, total body lift procedures) will be consented to use the Zalviso device in postoperative period as a main analgesia method.

Primary Outcome Measures

Name	Time	Method
System Usability Score	72 hours after use of Zalviso	A 10 items Licket type System Usability Score will be used in patients with ZALVISO® analgesia and in carrying ward nurses 72 hours the surgery per each case.

Secondary Outcome Measures

Name	Time	Method
Satisfaction Score	72 hours after use of Zalviso	100 points (0 - no satisfaction; 100 - entire satisfaction) satisfaction score will be used in physical therapist 72 hours after the surgery per each case.

Trial Locations

Locations (1)

Hôpital de la Croix Rousse - Service d'Anesthésie-Réanimation; 🇫🇷 Lyon, France