Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT04448457|
Recruitment Status : Completed
First Posted : June 25, 2020
Last Update Posted : June 25, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Sufentanil Sublingual Tablet Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sufentanil Sublingual Tablet System For Management Of Postoperative Pain In Enhanced Recovery After Surgery Pathway For Total Knee Arthroplasty: A Randomized Controlled Study|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||July 31, 2018|
Experimental: SSTS group
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
15 mcg with lockout interval of 20 min
Other Name: Zalviso
Active Comparator: 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
Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet
Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg
- Postoperative pain score assessed at 24 hours [ Time Frame: 24 hours after surgery ]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
- Postoperative pain scores assessed over 48 hours [ Time Frame: 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery ]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
- Time to first mobilization [ Time Frame: 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery ]Successful mobilization with or without aid assessed at specific timepoints
- Patient satisfaction [ Time Frame: At completion of the study period of 48 hours ]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.
- Incidence of nausea and vomiting [ Time Frame: At completion of the study period of 48 hours ]Percentage of patients who experienced nausea or vomiting during the study period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448457
|La Louviere, Belgium, 7100|
|Principal Investigator:||Emmanuel Noel, MD||CHU Tivoli|