Postoperative PainNCT04448457
Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty
A study testing Sufentanil Sublingual Tablet and Oxycodone oral tablet and oxycodone extended-release oral tablet in people with Postoperative Pain, run by Centre Hospitalier Universitaire de Tivoli at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Sufentanil Sublingual Tablet and Oxycodone oral tablet and oxycodone extended-release oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years)
- Scheduled for unilateral total knee arthroplasty under spinal anesthesia
- American Society of Anesthesiologists (ASA) class 1-3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Sufentanil Sublingual Tablet, Oxycodone oral tablet and oxycodone extended-release oral tablet
- Keywords
- SSTS, Oxycodone, Enhanced recovery after surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil Sublingual TabletDrug
Also called Zalviso
15 mcg with lockout interval of 20 min
Oxycodone oral tablet and oxycodone extended-release oral tabletDrug
Also called OxyNorm, OxyContin
Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg
| Study group | Role | What they receive |
|---|---|---|
| SSTS group | Experimental | Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively Receives: Drug: Sufentanil Sublingual Tablet |
| Oxycodone group | Active comparator | 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 Receives: Drug: Oxycodone oral tablet and oxycodone extended-release oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours after surgery
Secondary outcomes (3)
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
Measured: 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery
Time to first mobilization
Successful mobilization with or without aid assessed at specific timepoints
Measured: 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery
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.
Measured: At completion of the study period of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Sep 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Tivoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Noel, MD, Principal investigator, Centre Hospitalier Universitaire de Tivoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448457
- Sponsor's protocol ID
- P2017/348
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33216238
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04448457
- Acronym / sponsor ID
- P2017/348
- Conditions
- Postoperative Pain
- Keywords
- SSTS, Oxycodone, Enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de TivoliUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSTS group | Experimental | Drug: Sufentanil Sublingual TabletPatients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively |
| Oxycodone group | Active comparator | Drug: Oxycodone oral tablet and oxycodone extended-release oral tabletPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age ≥ 18 years)
- Scheduled for unilateral total knee arthroplasty under spinal anesthesia
- American Society of Anesthesiologists (ASA) class 1-3
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanil Sublingual TabletAlso: Zalviso15 mcg with lockout interval of 20 min | Drug | SSTS group |
| Oxycodone oral tablet and oxycodone extended-release oral tabletAlso: OxyNorm, OxyContinOxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg | Drug | Oxycodone group |
Primary outcome
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
3 secondary outcomes
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
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
Patient satisfaction
Time frame: At completion of the study period of 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Derived from this study: PubMed 33216238Noel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Noel, MD principal investigator
Centre Hospitalier Universitaire de Tivoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sufentanil Sublingual Tablet and Oxycodone oral tablet and oxycodone extended-release oral tablet in people with Postoperative Pain, run by Centre Hospitalier Universitaire de Tivoli at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score assessed at 24 hours (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.