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

Surgery Clinical Trial

— USE-SSPC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373851
• Other study ID #: 69HCL17_0511
• Status: Completed
• Start date: June 25, 2018
• Est. completion date: May 24, 2019

Study information

• Verified date: September 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgery
• Trauma

Intervention

Device:
• Zalviso 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.

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse - Service d'Anesthésie-Réanimation	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Usability Score	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.	72 hours after use of Zalviso
Secondary	Satisfaction Score	100 points (0 - no satisfaction; 100 - entire satisfaction) satisfaction score will be used in physical therapist 72 hours after the surgery per each case.	72 hours after use of Zalviso