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

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.

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Key information

Conditions

Trauma Surgery Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital de la Croix Rousse - Service d'Anesthésie-Réanimation

Lyon, 69004, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Zalviso Device

Device

The Zalviso device will be provided immediately before the Post anesthesia care unit (PACU) discharge. Patients will be queried every day during three postoperative days for the ability to use the device, their satisfaction, the level of pain, and the incidence of side effects. There will be no changes in usual care.

In the end of this study ward nurses carrying Zalviso patients will be asked to provide their usability and satisfaction evaluation for Zalviso device management. Physical therapist will be asked to provide their satisfaction regarding patients' ability to follow physical therapy program.

Primary outcomes

System Usability Score

Time frame: 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 outcomes

Satisfaction Score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Usability and Satisfaction Evaluation of Sufentanil Sublingual Patient-Controlled Analgesia After Elective Surgery With Moderate-to-Severe Postoperative Pain

Acronym: USE-SSPC

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Dec 14, 2017
Registry last updated: Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed