Postoperative Pain
Conditions
Keywords
SSTS, Oxycodone, Enhanced recovery after surgery
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.
Interventions
15 mcg with lockout interval of 20 min
DRUGOxycodone oral tablet and oxycodone extended-release oral tablet
Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg
Sponsors
Centre Hospitalier Universitaire de Tivoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of nausea and vomiting | At completion of the study period of 48 hours | Percentage of patients who experienced nausea or vomiting during the study period |
Countries
Belgium
Outcome results
None listed