Safety and Efficacy of Patient Controlled Analgesia Using the Sublingual Sufentanil Tablet System (SSTS) in a Fast Track Rehabilitation Program After Total Knee Arthroplasty

NCT ID: NCT04432428

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-26
• Study Completion Date: 2021-09-19

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sufentanil sublingual tablet

sufentanil sublingual 15µg tablets

Group Type: EXPERIMENTAL

Sufentanil Sublingual Tablet

Intervention Type: DRUG

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

Interventions

Sufentanil Sublingual Tablet

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 Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Wouters, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Luc Verbacnk, MD

Role: PRINCIPAL_INVESTIGATOR

Yperman Hospital

Locations

University Hospital Ghent

Ghent, Oost-Vlaanderen, Belgium

Countries

Belgium

Other Identifiers

2019/1741

Identifier Type: -

Identifier Source: org_study_id