Trial | NCT04448457  Report issue

Title

Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty
Sufentanil Sublingual Tablet System For Management Of Postoperative Pain In Enhanced Recovery After Surgery Pathway For Total Knee Arthroplasty: A Randomized Controlled Study

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    72
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.
Even with multimodal analgesia (combining local anesthetic infiltration, corticosteroids, non-steroidal anti-inflammatory drugs and acetaminophen), total knee arthroplasty is associated with acute moderate-to-severe postoperative pain requiring opioids treatment. We compare the efficacy of SSTS and oral Oxycodone in this context.

After written informed consent, patients will be randomly assigned postoperatively to SSTS or Oral oxycodone group at a ratio 1:1. Pain scores, mobilization and patient satisfaction will be analyzed.
Study Started
Sep 01
2017
Primary Completion
Jul 31
2018
Study Completion
Jul 31
2018
Last Update
Jun 25
2020

Drug Sufentanil Sublingual Tablet

15 mcg with lockout interval of 20 min

  • Other names: Zalviso

Drug Oxycodone oral tablet and oxycodone extended-release oral tablet

Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg

  • Other names: OxyNorm, OxyContin

SSTS group Experimental

Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively

Oxycodone group Active Comparator

Patients received oxycodone extended-release tablet (OxyContin) 10 mg every 12 hours systematically plus Oxycodone 5 mg every 6 hours if numeric rating scale is above 3 during the 48 hours postoperatively

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
No Results Posted