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

Sponsor

Centre Hospitalier Universitaire de Tivoli (Other)

Overall Status

Completed

CT.gov ID

NCT04448457

Collaborator

(none)

Enrollment

Location

Arms

10.9

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Sufentanil Sublingual Tablet Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Jul 31, 2018

Actual Study Completion Date :

Jul 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SSTS group Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively	Drug: Sufentanil Sublingual Tablet 15 mcg with lockout interval of 20 min Other Names: Zalviso
Active Comparator: Oxycodone group Patients received oxycodone extended-release tablet (OxyContin) 10 mg every 12 hours systematically plus Oxycodone 5 mg every 6 hours if numeric rating scale is above 3 during the 48 hours postoperatively	Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg Other Names: OxyNorm OxyContin

Arm

Intervention/Treatment

Experimental: SSTS group

Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively

Drug: Sufentanil Sublingual Tablet

15 mcg with lockout interval of 20 min

Other Names:

Zalviso

Active Comparator: Oxycodone group

Patients received oxycodone extended-release tablet (OxyContin) 10 mg every 12 hours systematically plus Oxycodone 5 mg every 6 hours if numeric rating scale is above 3 during the 48 hours postoperatively

Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet

Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg

Other Names:

OxyNorm

OxyContin

Outcome Measures

Primary Outcome Measures

Postoperative pain score assessed at 24 hours [24 hours after surgery]
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

Secondary Outcome Measures

Postoperative pain scores assessed over 48 hours [2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery]
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
Time to first mobilization [2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery]
Successful mobilization with or without aid assessed at specific timepoints
Patient satisfaction [At completion of the study period of 48 hours]
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.

Other Outcome Measures

Incidence of nausea and vomiting [At completion of the study period of 48 hours]
Percentage of patients who experienced nausea or vomiting during the study period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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