USE-SSPC: Sublingual Sufentanil PCA Usability for Postoperative Pain (Zalviso® System)

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT03373851
Collaborator
(none)
119
1
18.1
6.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Zalviso Device

Study Design

Study Type:
Observational
Actual Enrollment :
119 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Usability and Satisfaction Evaluation of Sufentanil Sublingual Patient-Controlled Analgesia After Elective Surgery With Moderate-to-Severe Postoperative Pain
Actual Study Start Date :
Jun 25, 2018
Actual Primary Completion Date :
Dec 28, 2019
Actual Study Completion Date :
Dec 28, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital de la Croix Rousse - Service d'Anesthésie-Réanimation Lyon France 69004

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03373851
Other Study ID Numbers:
  • 69HCL17_0511
First Posted:
Dec 14, 2017
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022