NCT04448457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

June 24, 2020

Last Update Submit

June 24, 2020

Conditions

Postoperative Pain

Keywords

SSTSOxycodoneEnhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours after surgery

Secondary Outcomes (3)

  • 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

  • Time to first mobilization

    2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery

  • Patient satisfaction

    At completion of the study period of 48 hours

Other Outcomes (1)

  • Incidence of nausea and vomiting

    At completion of the study period of 48 hours

Study Arms (2)

SSTS group

EXPERIMENTAL

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

Oxycodone group

ACTIVE COMPARATOR

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

Interventions

Sufentanil Sublingual TabletDRUG

15 mcg with lockout interval of 20 min

Also known as: Zalviso
SSTS group
Oxycodone oral tablet and oxycodone extended-release oral tabletDRUG

Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg

Also known as: OxyNorm, OxyContin
Oxycodone group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (age ≥ 18 years)
  • Scheduled for unilateral total knee arthroplasty under spinal anesthesia
  • American Society of Anesthesiologists (ASA) class 1-3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Tivoli

La Louvière, 7100, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 33216238DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

SufentanilOxycodone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Emmanuel Noel, MD

    Centre Hospitalier Universitaire de Tivoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 25, 2020

Study Start

September 1, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

June 25, 2020

Record last verified: 2020-06

Locations

BE(1)