Clinical trial NCT04432428: Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty
Official title: Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: knee surgery
Patient Controlled Analgesia (PCA)
Enhansed Recovery After Surgery (ERAS)
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicentric interventional prospective cohort study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Total time NRS<4
timeFrame: from end of surgery until 48 hours postoperatively
Secondary outcomes:
measure: length of hospital stay
timeFrame: from hospital admission until hospital discharge, up to 1 week post-operatively
measure: Incidence of the side effect nausea
timeFrame: from end of surgery until 72 hours postoperatively
measure: Incidence of the side effect vomiting
timeFrame: from end of surgery until 72 hours postoperatively
measure: Incidence of the side effect itching
timeFrame: from end of surgery until 72 hours postoperatively
measure: Incidence of the side effect drowsiness
timeFrame: from end of surgery until 72 hours postoperatively
measure: Incidence of the side effect constipation
timeFrame: from end of surgery until 72 hours postoperatively
measure: Oxygen desaturation
timeFrame: from end of surgery until 72 hours postoperatively
measure: patient satisfaction with Zalviso PCA
timeFrame: after discontinuation of study medication, up to 72 hrs after start of the study medication
measure: health care worker satisfaction with the patients pain treatment with Zalviso PCA
timeFrame: after patients discontinuation of study medication, up to 1 week after stop study medication
measure: consumption of study medication
timeFrame: from start administration of study medication until end of administration of study medication, up to a maximum of 72 hrs
measure: Level of analgesia during physiotherapy
timeFrame: from start until end of physiotherapy session, up to 2 days post-operatively
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: Oost-Vlaanderen
Study officials:
affiliation: University Hospital, Ghent
name: Patrick Wouters, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yperman Hospital
name: Luc Verbacnk, MD
role: PRINCIPAL_INVESTIGATOR
References: