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

• Status: Completed
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

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 rehabilitation program.

SSTS is a novel patient controlled analgesia system wich does not require intravenous access, potentially improving pain control and promoting mobilization.

SSTS will be randomly compared to nurse-driven oral Oxycodone.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Tivoli
• Treatments: Oxycodone; Sufentanil

Criteria

Inclusion Criteria:

• Adult patients (age ≥ 18 years)

• Scheduled for unilateral total knee arthroplasty under spinal anesthesia

• American Society of Anesthesiologists (ASA) class 1-3

Exclusion Criteria:

• 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