Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448457
• Other study ID #: P2017/348
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: June 2020
• Source: Centre Hospitalier Universitaire de Tivoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Sufentanil Sublingual Tablet
15 mcg with lockout interval of 20 min
• Oxycodone oral tablet and oxycodone extended-release oral tablet
Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg

Locations

Country	Name	City	State
Belgium	Chu Tivoli	La Louviere

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Tivoli

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of nausea and vomiting	Percentage of patients who experienced nausea or vomiting during the study period	At completion of the study period of 48 hours
Primary	Postoperative pain score assessed at 24 hours	A numerical pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest and dynamically 24 hours after surgery	24 hours after surgery
Secondary	Postoperative pain scores assessed over 48 hours	A numerical pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest and dynamically	2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery
Secondary	Time to first mobilization	Successful mobilization with or without aid assessed at specific timepoints	2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery
Secondary	Patient satisfaction	Satisfaction for the method of pain control assessed using Patient Global Assessment (PGA) of the method of pain control questionnaire at the completion of the 48h study period which consist on a 4-point categorical scale, where 1 = poor, 2 = fair, 3 = good, and 4 = excellent.	At completion of the study period of 48 hours