Back to resultsSufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Sufentanil Sublingual Tablet
Oxycodone oral tablet and oxycodone extended-release oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring SSTS, Oxycodone, Enhanced recovery after surgery
Eligibility Criteria
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
Sites / Locations
- Chu Tivoli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SSTS group
Oxycodone group
Arm Description
Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Time to first mobilization
Successful mobilization with or without aid assessed at specific timepoints
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.
Full Information
NCT ID
NCT04448457
First Posted
June 24, 2020
Last Updated
June 24, 2020
Sponsor
Centre Hospitalier Universitaire de Tivoli
1. Study Identification
Unique Protocol Identification Number
NCT04448457
Brief Title
Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Tivoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
SSTS, Oxycodone, Enhanced recovery after surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SSTS group
Arm Type
Experimental
Arm Description
Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively
Arm Title
Oxycodone group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sufentanil Sublingual Tablet
Other Intervention Name(s)
Zalviso
Intervention Description
15 mcg with lockout interval of 20 min
Intervention Type
Drug
Intervention Name(s)
Oxycodone oral tablet and oxycodone extended-release oral tablet
Other Intervention Name(s)
OxyNorm, OxyContin
Intervention Description
Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg
Primary Outcome Measure Information:
Title
Postoperative pain score assessed at 24 hours
Description
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
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative pain scores assessed over 48 hours
Description
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 Frame
2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery
Title
Time to first mobilization
Description
Successful mobilization with or without aid assessed at specific timepoints
Time Frame
2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery
Title
Patient satisfaction
Description
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.
Time Frame
At completion of the study period of 48 hours
Other Pre-specified Outcome Measures:
Title
Incidence of nausea and vomiting
Description
Percentage of patients who experienced nausea or vomiting during the study period
Time Frame
At completion of the study period of 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Noel, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Tivoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Tivoli
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
33216238
Citation
Noel E, Miglionico L, Leclercq M, Jennart H, Fils JF, Van Rompaey N. Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study. J Exp Orthop. 2020 Nov 20;7(1):92. doi: 10.1186/s40634-020-00306-x.
Results Reference
derived
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Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty
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