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

NCT03373851 | Completed

• 1 other identifier: 69HCL17_0511
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Satisfaction Score

  72 hours after use of Zalviso

Study Arms (1)

Zalviso

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.

Device: Zalviso Device

Interventions

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.

Zalviso

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with major functional surgery associated with moderate-to severe postoperative pain in the enhanced recovery settings.

You may qualify if:

• Adults
• \<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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Lyon, 69004, France

Location

Related Publications (1)

• Amson H, Lasselin P, Naegels B, Pardey Bracho GF, Aubrun F, Dziadzko M. Usability evaluation of sufentanil sublingual tablet analgesia in patients following Enhanced Recovery After Surgery. J Comp Eff Res. 2021 Jun;10(9):743-750. doi: 10.2217/cer-2020-0239. Epub 2021 Apr 21.

  PMID: 33880939 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Frédéric AUBRUN, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Mikhail DZIADZKO, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 14, 2017
• Study Start: June 25, 2018
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)