NCT04432428

Brief Summary

The sufentanil sublingual tablet system (SSTS) is an innovative patient-controlled analgesia (PCA) device for the management of acute moderate to severe postoperative pain in hospital settings in adult patients. The SSTS is non-invasive and imposes no restrictions on patient mobility, which renders it particularly suitable for clinical conditions where early mobilization is a key component of successful surgical outcome. The present study tests the hypothesis that SSTS is an efficient and safe analgesic technique allowing fast track rehabilitation after total knee arthroplasty in a prospective cohort design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started May 2020

Typical duration for phase_4 postoperative-pain

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

May 26, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2021

Completed
Last Updated

December 6, 2022

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

June 8, 2020

Last Update Submit

December 3, 2022

Conditions

Postoperative Pain

Keywords

knee surgeryPatient Controlled Analgesia (PCA)Enhansed Recovery After Surgery (ERAS)

Outcome Measures

Primary Outcomes (1)

  • Total time NRS<4

    cumulative time that patient had NRS\<4

    from end of surgery until 48 hours postoperatively

Secondary Outcomes (11)

  • length of hospital stay

    from hospital admission until hospital discharge, up to 1 week post-operatively

  • Incidence of the side effect nausea

    from end of surgery until 72 hours postoperatively

  • Incidence of the side effect vomiting

    from end of surgery until 72 hours postoperatively

  • Incidence of the side effect itching

    from end of surgery until 72 hours postoperatively

  • Incidence of the side effect drowsiness

    from end of surgery until 72 hours postoperatively

  • +6 more secondary outcomes

Study Arms (1)

sufentanil sublingual tablet

EXPERIMENTAL

sufentanil sublingual 15µg tablets

Drug: Sufentanil Sublingual Tablet

Interventions

Sufentanil Sublingual TabletDRUG

all patients will receive tablets for sublingual use, containing 15 microgram of sufentanil. The sufentanil tablets come in a cartridge (40 tablets) and are administered with a special patient-controlled device that uses thumb tag recognition. max dose per hour : 3 tablets of 15µg sufentanil

sufentanil sublingual tablet

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients between 40-75 years old
  • Able to give consent
  • Scheduled of elective knee arthroplasty with a fast rehabilitation program
  • Able to understand PCA principle and capable to operate SSTS device

You may not qualify if:

  • Outside age range
  • Contra indication for anti-inflammatory drugs
  • Revision total knee arthroplasty
  • history of substance abuse,
  • pregnancy,lactation
  • severe hepatic impairment (INR\>1,5 and/or AST/ALT above x3 highest normal value),
  • sleep apnea (documented by sleep laboratory study),
  • severe chronic kidney disease (eGFR\<30 mL/min/1.73 m2),
  • severe and very severe COPD (GOLD III and IV)
  • opioid tolerance (use of \>15mg oral morphine equivalent per day within the past 3 months),
  • chronic pain conditions necessitating gabapentinoids, steroids or anti-inflammatory drugs
  • hypersensitivity to sufentanil
  • significant respiratory depression (need for outpatient supplemental oxygen therapy),
  • participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Patrick Wouters, MD PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

  • Luc Verbacnk, MD

    Yperman Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Multicentric interventional prospective cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 16, 2020

Study Start

May 26, 2020

Primary Completion

August 31, 2021

Study Completion

September 19, 2021

Last Updated

December 6, 2022

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)