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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Sufentanil Sublingual Tablet Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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
Other Names:
  • OxyNorm
  • OxyContin




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Belgium
Chu Tivoli
La Louviere, Belgium, 7100
Sponsors and Collaborators
Centre Hospitalier Universitaire de Tivoli
Investigators
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Principal Investigator: Emmanuel Noel, MD CHU Tivoli
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Tivoli
ClinicalTrials.gov Identifier: NCT04448457    
Other Study ID Numbers: P2017/348
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Tivoli:
SSTS
Oxycodone
Enhanced recovery after surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Sufentanil
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics