Orthopedic SurgeryPhase 3NCT05831345
Intraoperative Methadone for the Prevention of Postoperative Pain
A Phase 3 study testing Methadone Hydrochloride and Sufentanil Citrate in people with Orthopedic Surgery, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
The pain felt after orthopedic surgery in the absence of adequate locoregional anesthesia is often insufficiently controlled, especially during the first 24 hours postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- Methadone Hydrochloride and Sufentanil Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Feb 2023to Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old
- ASA 1-3 status
- Elective partial or total hip and knee arthroplasty
Who cannot join
- Patient refusal
- Preoperative renal failure (serum creatinine > 2 mg/dL or 1.5-fold
- Increase in basal plasma creatinine or GFR < 90 ml/min/1.73m2)
- Significant hepatic dysfunction (PT <50% or increase in 3 times basal transaminases)
- Known heart failure
- Preoperative hemodynamic instability (preoperative use of inotropes or vasopressors)
Show all 9Show fewer
- Known methadone or sufentanil allergy
- Preoperative opioid use or history of opioid abuse
- Pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Riccardo Mora, MD, 00393292199132, riccardo.mora@chu-brugmann.be
About this study
Official title: Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery
The pain felt after orthopedic surgery in the absence of adequate locoregional anesthesia is often insufficiently controlled, especially during the first 24 hours postoperatively.
Methadone, due to its long half-life, may provide better pain control after orthopedic surgery when associated locoregional anesthesia cannot be performed.
Read more
It may be impossible to perform loco-regional anesthesia in various contexts: patient refusal, pre-existing neurological impairment, infection at the injection site, coagulopathies, inability to cooperate, total language barrier, allergy to anesthetics, unavailability of equipment (ultrasound, etc.) or equipped room, lack of experience of nursing staff in performing the block and in the postoperative management of the patient.
Intraoperative administration of methadone in these settings may be superior to sufentanil for pain control during the 24 hours post orthopedic surgery, and the pain control provided by methadone does not appear to imply a higher likelihood of adverse events related to opioids.
- Conditions
- Orthopedic Surgery
- Being tested
- Methadone Hydrochloride, Sufentanil Citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone HydrochlorideDrug
Classic induction of anesthesia (opioid, hypnotic and curare) but the team is blinded to the opioid used (sufentanil or methadone), which is prepared in identical syringes by the pharmacy
Sufentanil CitrateDrug
Classic induction of anesthesia (opioid, hypnotic and curare) but the team is blinded to the opioid used (sufentanil or methadone), which is prepared in identical syringes by the pharmacy
| Study group | Role | What they receive |
|---|---|---|
| S Group | Active comparator | Patients receiving sufentanil during induction of general anesthesia Receives: Drug: Sufentanil Citrate |
| M Group | Experimental | Patients receiving methadone during induction of general anesthesia Receives: Drug: Methadone Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Total morphine consumption
Measured: 72 hours
Standard visual analogue scale (VAS)
Pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 (no pain) to 10 (worst pain))
Measured: 24 hours
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction is assessed by means of a questionnaire at the end of hospital stay
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start28 Feb 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic SurgeryStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Besse-Hammer, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831345
- Sponsor's protocol ID
- CHUB-Methadone
- Status last verified
- Feb 2025
- First submitted
- 14 Apr 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT05831345
- Acronym / sponsor ID
- CHUB-Methadone
- Conditions
- Orthopedic Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Apr 2023 (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 pain felt after orthopedic surgery in the absence of adequate locoregional anesthesia is often insufficiently controlled, especially during the first 24 hours postoperatively.
Methadone, due to its long half-life, may provide better pain control after orthopedic surgery when associated locoregional anesthesia cannot be performed.
It may be impossible to perform loco-regional anesthesia in various contexts: patient refusal, pre-existing neurological impairment, infection at the injection site, coagulopathies, inability to cooperate, total language barrier, allergy to anesthetics, unavailability of equipment (ultrasound, etc.) or equipped room, lack of experience of nursing staff in performing the block and in the postoperative management of the patient.
Intraoperative administration of methadone in these settings may be superior to sufentanil for pain control during the 24 hours post orthopedic surgery, and the pain control provided by methadone does not appear to imply a higher likelihood of adverse events related to opioids.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S Group | Active comparator | Drug: Sufentanil CitratePatients receiving sufentanil during induction of general anesthesia |
| M Group | Experimental | Drug: Methadone HydrochloridePatients receiving methadone during induction of general anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 80 years old
- ASA 1-3 status
- Elective partial or total hip and knee arthroplasty
Key exclusion criteria (9 listed)
- Patient refusal
- Preoperative renal failure (serum creatinine > 2 mg/dL or 1.5-fold
- Increase in basal plasma creatinine or GFR < 90 ml/min/1.73m2)
- Significant hepatic dysfunction (PT <50% or increase in 3 times basal transaminases)
- Known heart failure
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 |
|---|---|---|
| Methadone HydrochlorideClassic induction of anesthesia (opioid, hypnotic and curare) but the team is blinded to the opioid used (sufentanil or methadone), which is prepared in identical syringes by the pharmacy | Drug | M Group |
| Sufentanil CitrateClassic induction of anesthesia (opioid, hypnotic and curare) but the team is blinded to the opioid used (sufentanil or methadone), which is prepared in identical syringes by the pharmacy | Drug | S Group |
Primary outcome
Total morphine consumption
Time frame: 72 hours
Total morphine consumption
Standard visual analogue scale (VAS)
Time frame: 24 hours
Pain is assessed using a standard visual analogue scale (VAS) in 11 points (from 0 (no pain) to 10 (worst pain))
1 secondary outcome
Patient satisfaction
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methadone Hydrochloride and Sufentanil Citrate in people with Orthopedic Surgery, run by Brugmann University Hospital 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 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Mora, MD (00393292199132, riccardo.mora@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 7 Feb 2025.