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

Study Overview
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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.

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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Sufentanil Sublingual Tablet
* Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSTS group<br>Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively | Drug: Sufentanil Sublingual Tablet<br>* 15 mcg with lockout interval of 20 min<br>* Other names: Zalviso;|
| Active Comparator: Oxycodone group<br>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 | Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet<br>* Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg<br>* Other names: OxyContin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score assessed at 24 hours | A numerical pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain at rest and dynamically 24 hours after surgery | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores assessed over 48 hours | A numerical pain scale anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) will be used to evaluate pain at rest and dynamically | 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery | 
| Time to first mobilization | Successful mobilization with or without aid assessed at specific timepoints | 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery | 
| Patient satisfaction | Satisfaction for the method of pain control assessed using Patient Global Assessment (PGA) of the method of pain control questionnaire at the completion of the 48h study period which consist on a 4-point categorical scale, where 1 = poor, 2 = fair, 3 = good, and 4 = excellent. | At completion of the study period of 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SSTS, Oxycodone, Enhanced recovery after surgery