Status:

COMPLETED

Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty

Lead Sponsor:

Centre Hospitalier Universitaire de Tivoli

Conditions:

Postoperative Pain

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The aim of this study is to assess the effectiveness of Sublingual Sufentanil Tablets System (SSTS, Zalviso ®) to control postoperative pain after total knee arthroplasty in the context of early rehab...

Detailed Description

Even with multimodal analgesia (combining local anesthetic infiltration, corticosteroids, non-steroidal anti-inflammatory drugs and acetaminophen), total knee arthroplasty is associated with acute mod...

Eligibility Criteria

Inclusion

  • Adult patients (age ≥ 18 years)
  • Scheduled for unilateral total knee arthroplasty under spinal anesthesia
  • American Society of Anesthesiologists (ASA) class 1-3

Exclusion

  • Contraindication to medication used in our multimodal analgesia protocol (solumedrol, celecoxib, acetaminophen, ropivacaine)
  • Allergy to study medications
  • History of addiction or preoperative chronic use of opioids
  • Unicompartmental or revision knee replacement

Key Trial Info

Start Date :

September 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2018

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT04448457

Start Date

September 1 2017

End Date

July 31 2018

Last Update

June 25 2020

Active Locations (1)

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1

Chu Tivoli

La Louvière, Belgium, 7100