AnalgesiaPhase 4NCT05259098
Morphine vs Sufentanil PCA: Same Same or Different?
A Phase 4 study testing Sufentanil Sublingual Tablet System in people with Analgesia and Post Operative Pain, run by Hospital Central do Funchal at 1 site in Portugal.
Trial summary
Patient-controlled intravenous analgesia (PCA) has already proven its quality. However, with new strategies starting to emerge and the current concept of opioid sparing, it is a goal to find the optimal PCA strategy capable of improve patient satisfaction and, at the same time, individualize opioid dose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Post Operative Pain, Patient Satisfaction
- What is being tested?
- Sufentanil Sublingual Tablet System
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2019to 31 Oct 2020
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent signed;
- Age superior to 18 years;
- Physical status according to the American Society of Anesthesiology (ASA) 1-3;
- Scheduled gynecological surgery: abdominal hysterectomy
- Scheduled orthopedic surgery: total knee arthroplasty or total hip arthroplasty.
Who cannot join
- Patient refusal to participate in the study;
- Age <18 years or legal dependence;
- Neurological or psychiatric pathology or altered state of consciousness that does not allow for the Patient Controlled Analgesia strategy;
- Documented drinking habits and/or consumption of illicit drugs;
- Patients tolerant to opioid therapy (use of >15 mg oral morphine or its equivalent per day for the last 3 months);
- Documented obstructive Sleep Apnea Syndrome (OSAS);
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- Patients on long-term oxygen therapy;
- Intraoperative use of intrathecal morphine;
- Use of anesthetic techniques in order to provide postoperative analgesia (eg, epidural catheter; peripheral nerve block; infiltration of the surgical wound with local anesthetic).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Sufentanil Sublingual Tablet System vs Intravenous Patient-Controlled Analgesia With Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery
Patient-controlled intravenous analgesia (PCA) has already proven its quality. However, with new strategies starting to emerge and the current concept of opioid sparing, it is a goal to find the optimal PCA strategy capable of improve patient satisfaction and, at the same time, individualize opioid dose.
In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System with intravenous PCA Morphine in terms of postoperative pain control satisfaction, total dose of opioid required, adverse effects, impact on the quality of postoperative recovery and the incidence of postoperative chronic pain.
Read the detailed description
In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System (15mcg per tablet, 20 minutes lockout) with intravenous PCA Morphine based on 1mg morphine on-demand 10 minutes lockout and a baseline perfusion of 1mg/hour.
45 patients capable of comply a PCA regime submitted to total knee arthroplasty, total hip arthroplasty and abdominal hysterectomy were enrolled in the study. During the first 48 hours, it was accessed daily pain scores, PCA use, need for rescue therapy, adverse effects, global satisfaction as well as postoperative quality recovery. Brief Pain Inventory was performed before surgery and 4 months later.
- Conditions
- Analgesia, Post Operative Pain, Patient Satisfaction, Chronic Pain
- Being tested
- Sufentanil Sublingual Tablet System, Intravenous Patient-Controlled Analgesia with morfine
- Medical subject headings
- Agnosia, Pain, Postoperative, Patient Satisfaction, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil Sublingual Tablet SystemDrug
Also called zalviso
Sufentanil Sublingual Tablet System is a sublingual opioid patient controlled analgesia system. It was used for postoperative analgesia after surgery associated with moderate to severe pain.
Intravenous Patient-Controlled Analgesia with morfineDrug
Intravenous Patient-Controlled Analgesia with morfine. It was used for postoperative analgesia after surgery associated with moderate to severe pain.
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil Sublingual Tablet System | Experimental | Group treated with Sufentanil Sublingual Tablet System Receives: Drug: Sufentanil Sublingual Tablet System |
| Intravenous Patient-Controlled Analgesia with Morphine | Experimental | Group treated with intravenous Patient-Controlled Analgesia with Morphine Receives: Drug: Intravenous Patient-Controlled Analgesia with morfine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain control
Comparison between patient controlled analgesia with IV morphine and sublingual sufentanil in Numeric Rating Scale
Measured: Evaluation at 24 hours and 48 hours after surgery
Secondary outcomes (5)
Adverse effects associated with analgesia
Evaluation of adverse effects of the PCA systems: sedation using the Richamond Agitation Sedation Scale (RASS); hypoxemia without oxygen supplementation: mild to moderate (SpO2 90-93%) or severe (SpO2<90%); hypotension; nausea or vomiting; dyspepsia; itching
Measured: Evaluation at 24 hours and 48 hours after surgery
Total daily dose of opioid
Evaluation of total daily dose of each drug
Measured: Evaluation at 24 hours and 48 hours after surgery
Patients satisfaction with analgesia
Evaluation of patient satisfaction using a qualitative scale: "Poor"; "Average"; "Good"; "Excellent"
Measured: Evaluation at 24 hours and 48 hours after surgery
Impact of the treatment on the quality of postoperative recovery
Evaluation of recovery with application of validated quality of recovery score (QoR-15) questionnaire
Measured: Evaluation at 24 hours after surgery
Incidence of postoperative chronic pain
Assessment to persistent postoperative pain by completing the Brief Pain Inventory
Measured: 4 months after surgey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Oct 2019
- Primary completion30 Jun 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Central do Funchal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana isabel freitas amorim, Hospital Central do Funchal
- Investigators
- Ana IPG Pereira, Medical, Principal investigator, Hospital Central do Funchal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259098
- Sponsor's protocol ID
- 35/2019
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Sufentanil Sublingual Tablet System vs Intravenous Patient-Controlled Analgesia With Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery
- ClinicalTrials.gov ID
- NCT05259098
- Acronym / sponsor ID
- 35/2019
- Conditions
- Analgesia, Post Operative Pain, Patient Satisfaction, Chronic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hospital Central do FunchalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 28 Feb 2022 (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.
Patient-controlled intravenous analgesia (PCA) has already proven its quality. However, with new strategies starting to emerge and the current concept of opioid sparing, it is a goal to find the optimal PCA strategy capable of improve patient satisfaction and, at the same time, individualize opioid dose.
In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System with intravenous PCA Morphine in terms of postoperative pain control satisfaction, total dose of opioid required, adverse effects, impact on the quality of postoperative recovery and the incidence of postoperative chronic pain.
Detailed description
In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System (15mcg per tablet, 20 minutes lockout) with intravenous PCA Morphine based on 1mg morphine on-demand 10 minutes lockout and a baseline perfusion of 1mg/hour.
45 patients capable of comply a PCA regime submitted to total knee arthroplasty, total hip arthroplasty and abdominal hysterectomy were enrolled in the study. During the first 48 hours, it was accessed daily pain scores, PCA use, need for rescue therapy, adverse effects, global satisfaction as well as postoperative quality recovery. Brief Pain Inventory was performed before surgery and 4 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil Sublingual Tablet System | Experimental | Drug: Sufentanil Sublingual Tablet SystemGroup treated with Sufentanil Sublingual Tablet System |
| Intravenous Patient-Controlled Analgesia with Morphine | Experimental | Drug: Intravenous Patient-Controlled Analgesia with morfineGroup treated with intravenous Patient-Controlled Analgesia with Morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent signed;
- Age superior to 18 years;
- Physical status according to the American Society of Anesthesiology (ASA) 1-3;
- Scheduled gynecological surgery: abdominal hysterectomy
- Scheduled orthopedic surgery: total knee arthroplasty or total hip arthroplasty.
Key exclusion criteria (9 listed)
- Patient refusal to participate in the study;
- Age <18 years or legal dependence;
- Neurological or psychiatric pathology or altered state of consciousness that does not allow for the Patient Controlled Analgesia strategy;
- Documented drinking habits and/or consumption of illicit drugs;
- Patients tolerant to opioid therapy (use of >15 mg oral morphine or its equivalent per day for the last 3 months);
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 Tablet SystemAlso: zalvisoSufentanil Sublingual Tablet System is a sublingual opioid patient controlled analgesia system. It was used for postoperative analgesia after surgery associated with moderate to severe pain. | Drug | Sufentanil Sublingual Tablet System |
| Intravenous Patient-Controlled Analgesia with morfineIntravenous Patient-Controlled Analgesia with morfine. It was used for postoperative analgesia after surgery associated with moderate to severe pain. | Drug | Intravenous Patient-Controlled Analgesia with Morphine |
Primary outcome
Postoperative pain control
Time frame: Evaluation at 24 hours and 48 hours after surgery
Comparison between patient controlled analgesia with IV morphine and sublingual sufentanil in Numeric Rating Scale
5 secondary outcomes
Adverse effects associated with analgesia
Time frame: Evaluation at 24 hours and 48 hours after surgery
Total daily dose of opioid
Time frame: Evaluation at 24 hours and 48 hours after surgery
Patients satisfaction with analgesia
Time frame: Evaluation at 24 hours and 48 hours after surgery
Impact of the treatment on the quality of postoperative recovery
Time frame: Evaluation at 24 hours after surgery
Incidence of postoperative chronic pain
Time frame: 4 months after surgey
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 28 Feb 2022.
- Individual participant dataSharing planned: Yes
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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.
Ana IPG Pereira, Medical principal investigator
Hospital Central do Funchal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sufentanil Sublingual Tablet System in people with Analgesia and Post Operative Pain, run by Hospital Central do Funchal at 1 site in Portugal.
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 5 inclusion and 9 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 28 Feb 2022. 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 Portugal. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 control (time frame: Evaluation at 24 hours and 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2022.