Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT04448457
- Lead Sponsor
- Centre Hospitalier Universitaire de Tivoli
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Adult patients (age ≥ 18 years)
- Scheduled for unilateral total knee arthroplasty under spinal anesthesia
- American Society of Anesthesiologists (ASA) class 1-3
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxycodone group Oxycodone oral tablet and oxycodone extended-release oral tablet 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 SSTS group Sufentanil Sublingual Tablet Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively
- Primary Outcome Measures
Name Time Method Postoperative pain score assessed at 24 hours 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
- Secondary Outcome Measures
Name Time Method Postoperative pain scores assessed over 48 hours 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 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 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.
Trial Locations
- Locations (1)
Chu Tivoli
🇧🇪La Louviere, Belgium