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Completed

NCT Number: NCT04448457

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Tivoli

La Louvière, 7100, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil Sublingual Tablet

Drug

15 mcg with lockout interval of 20 min

Other names: Zalviso

Oxycodone oral tablet and oxycodone extended-release oral tablet

Drug

Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg

Other names: OxyNorm, OxyContin

Primary outcomes

  1. Postoperative pain score assessed at 24 hours

    Time frame: 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 outcomes

  1. Postoperative pain scores assessed over 48 hours

    Time frame: 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

  2. Time to first mobilization

    Time frame: 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

  3. Patient satisfaction

    Time frame: 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 outcomes

  1. Incidence of nausea and vomiting

    Time frame: At completion of the study period of 48 hours

    Percentage of patients who experienced nausea or vomiting during the study period

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Tivoli

Other

Registry information

Official study title

Sufentanil Sublingual Tablet System For Management Of Postoperative Pain In Enhanced Recovery After Surgery Pathway For Total Knee Arthroplasty: A Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 25, 2020
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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