Clinical trial NCT04448457: Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty
Official title: Sufentanil Sublingual Tablet System For Management Of Postoperative Pain In Enhanced Recovery After Surgery Pathway For Total Knee Arthroplasty: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: SSTS
Oxycodone
Enhanced recovery after surgery
Lead sponsor: Centre Hospitalier Universitaire de Tivoli
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Even with multimodal analgesia (combining local anesthetic infiltration, corticosteroids, non-steroidal anti-inflammatory drugs and acetaminophen), total knee arthroplasty is associated with acute moderate-to-severe postoperative pain requiring opioids treatment. We compare the efficacy of SSTS and oral Oxycodone in this context.

After written informed consent, patients will be randomly assigned postoperatively to SSTS or Oral oxycodone group at a ratio 1:1. Pain scores, mobilization and patient satisfaction will be analyzed.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postoperative pain score assessed at 24 hours
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Postoperative pain scores assessed over 48 hours
timeFrame: 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery
measure: Time to first mobilization
timeFrame: 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery
measure: Patient satisfaction
timeFrame: At completion of the study period of 48 hours
Other outcomes:
measure: Incidence of nausea and vomiting
timeFrame: At completion of the study period of 48 hours
Locations:
city: La Louviere
country: Belgium
facility: Chu Tivoli
Study officials:
affiliation: Centre Hospitalier Universitaire de Tivoli
name: Emmanuel Noel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.