Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Total knee arthroplasty is one of the most common major procedures performed today with a
      significant impact on health care budgets. Fast track rehabilitation programmes are being
      developed to control hospitalization costs associated with this procedure. Interestingly,
      such pathway controlled fast track programs also appear to enhance functional recovery and to
      reduce complications. These beneficial effects are mainly attributed to the practice of rapid
      mobilization and early intensified physiotherapy which can only be achieved with effective
      analgesic techniques.

      Current PCA techniques - predominantly morphine based - are the gold standard for this
      purpose but they involve intravenous access and a programmable computer system requiring
      close supervision. Reported shortcomings are systems failure leading to analgesic gaps, drug
      errors and restrictions in mobility since patients are tethered to IV poles. The SSTS may
      overcome these limitations because the opioid used, sufentanil, has a more predictable time
      of onset, the delivery system does not require programming, and the device does not limit
      patient's mobility. It retains the benefits of potent analgesia as well as patient
      empowerment and is particularly suited to target the analgesic effect precisely to the level
      required in physiotherapeutic sessions.

      The present study will test the hypothesis that SSTS is an efficient and safe analgesic
      technique allowing fast track rehabilitation after total knee arthroplasty in a prospective
      cohort design.

      The study will focus on the efficiency of STSS which is defined as 75% or more of the treated
      patients proves NRS score less than 4 during 48 hours postoperatively, additionally to the
      basic pain treatment (paracetamol and NSAID).

      The STSS will allow the patient tot take a maximum of 3 doses in one hour. Treatment with the
      STSS is continued over a period of 48 hours or if necessary up to 72 hours.

      During this period the patients pain en parameters will be monitored closely.

      The maximum administered total dose of Zalviso will not exceed 1.2mg.
    

Intervention name(s): Sufentanil Sublingual Tablet
Intervention type(s): Drug
Intervention description(s): 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
Intervention MeSH terms: Sufentanil
Intervention model: Single Group Assignment
Intervention model description: Multicentric interventional prospective cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee surgery; Patient Controlled Analgesia (PCA); Enhansed Recovery After Surgery (ERAS)