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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SSTS group

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

Group Type EXPERIMENTAL

Sufentanil Sublingual Tablet

Intervention Type DRUG

15 mcg with lockout interval of 20 min

Oxycodone group

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

Group Type ACTIVE_COMPARATOR

Oxycodone oral tablet and oxycodone extended-release oral tablet

Intervention Type DRUG

Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg

Interventions

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Sufentanil Sublingual Tablet

15 mcg with lockout interval of 20 min

Intervention Type DRUG

Oxycodone oral tablet and oxycodone extended-release oral tablet

Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg

Intervention Type DRUG

Other Intervention Names

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Zalviso OxyNorm OxyContin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No