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

NCT04448457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-06-25

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Sufentanil Sublingual Tablet

15 mcg with lockout interval of 20 min

DRUG

Oxycodone oral tablet and oxycodone extended-release oral tablet

Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Tivoli

    lead OTHER

Principal Investigators

  • Emmanuel Noel, MD · Centre Hospitalier Universitaire de Tivoli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04448457 on ClinicalTrials.gov