Pain, PostoperativeMETAMORFNCT04475029
Methadone in Cystectomy Patients
A study testing Methadone and Morphine in people with Pain, Postoperative and Postoperative Complications, run by University of Aarhus at 1 site in Denmark.
Trial summary
The role of a single-dose intraoperative methadone on postoperative pain and opioid consumption in patients undergoing Surgeon Accuracy Robot Assistant cystectomy. A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Pain, Postoperative, Postoperative Complications, Pathologic Processes
- What is being tested?
- Methadone and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Jul 2020to 17 Aug 2023
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients (≥18 years) scheduled for elective robot assisted cystectomy.
Who cannot join
- American Society of Anesthesiologists (ASA) physical status IV or V
- Prolonged QTc-interval assessed by electrocardiogram (> 440 milliseconds)
- Existing treatment with a high risk of QTc-interval prolongation
- Allergy to study drugs
- Preoperative daily use of opioids
- Inability to provide informed consent
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- Severe respiratory insufficiency (oxygen treatment at home)
- Heart failure (ejection fraction < 30%)
- Acute abdominal pain
- Signs of severe liver dysfunction (cirrhosis, inflammation/hepatitis or liver malignancy)
- Severe kidney insufficiency (estimated Glomerular Filtration Rate < 30 ml/min)
- Treatment with rifampicin
- Phaeochromocytoma
- Treatment with MAO-inhibitor during the last 14 days
- Pregnancy
- Nursing mothers
- Intraoperative conversion to open surgery (secondary inclusion criterion)
- Epidural analgesia in relation to surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effectiveness and Safety of Intraoperative Methadone in Patients
The role of a single-dose intraoperative methadone on postoperative pain and opioid consumption in patients undergoing Surgeon Accuracy Robot Assistant cystectomy. A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing robotassisted cystectomy.
Read the detailed description
During early recovery after surgery, intravenous opioids are typically administered to control the pain, either as intermittent bolus administration by nursing staff or by a patient-controlled analgesia device. Unfortunately, repeated doses or boluses of shorter-acting opioids, such as morphine, oxycodone and fentanyl, result in fluctuating blood concentrations, with the inherent risk of only relatively brief periods of adequate pain relief. Moreover, the use of shorter-acting opioids increases the risk of opioid-associated side effects, such as sedation, nausea and vomiting. An alternative approach to the postoperative use of shorter-acting opioids is therefore called for.
In this respect, methadone is an opioid with unique pharmalogical properties that may be advantageous when applied intraoperatively. A single-dose of this long acting opioid could provide a stable analgesia and potentially reduce the need for shorter-acting opioids
Method:
110 patients will be included in an investigator-initiated, prospective, randomised, double-blind, controlled trial with two arms: intervention arm (methadone 0.15 mg/kg ideal body weight). Control arm (morphine 0.15 mg/kg ideal body weight). The study will be GCP-monitored, and is approved by the Danish Health and Medicines Authority (2020041652) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-275-19).
Hypothesis We hypothesize that a single-dose of intravenous intraoperative methadone is efficient and safe for the treatment of postoperative pain after cystectomy.
Objectives The primary objective is to determine whether a single-dose of intravenous methadone reduces postoperative opioid consumption when compared to morphine. The secondary objectives are to compare the effect and safety of intravenous methadone and morphine on postoperative pain, side effects, patient satisfaction and length of stay.
- Conditions
- Pain, Postoperative, Postoperative Complications, Pathologic Processes, Bladder Cancer, Pain, Signs and Symptoms
- Being tested
- Methadone, Morphine
- Keywords
- morphine, methadone, analgesics, opioids, effect of drugs
- Medical subject headings
- Pain, Postoperative, Postoperative Complications, Pathologic Processes, Urinary Bladder Neoplasms, Pain, Signs and Symptoms, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
One intravenous administration of methadone (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.
MorphineDrug
One intravenous administration of morphine (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Experimental | A 10 ml syringe with 2 mg/ml of methadone will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation. Receives: Drug: Methadone |
| Morphine | Active comparator | A 10 ml syringe with 2 mg/ml of morphine will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption (morphine mg equivalents)
- Opioid consumption within the first 3 hours after extubation
Measured: 3 hours
Opioid consumption (morphine mg equivalents)
- Opioid consumption within the first 24 hours after extubation
Measured: 24 hours
Secondary outcomes (7)
Pain intensity
NRS (0-10) at rest and when coughing. Questionnaires answered by nurse.
Measured: within 24 hours
Opioid consumption (morphine mg equivalents)
- Opioid consumption within the first 72 hours after extubation
Measured: 72 hours
PONV
- Nausea and/or vomiting (PONV) on a 4-point Likert scale (none/mild/moderate/severe). Questionnaires answered by nurse.
Measured: Within 24 hours
Level of sedation
Level of sedation (Ramsey Sedation Score) assessed by PACU nurse.
Measured: 3 hours
Adverse events
Any adverse events registered.
Measured: 6 hours
Patient satisfaction from 0-10.
Patient satisfaction with pain management (NRS 0-10) Questionnaires answered by nurse.
Measured: 24 hours
Discharge
- Time from arrival to discharge from PACU and hospital (hours and minutes)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start6 Jul 2020
- Primary completion15 Aug 2023
- Study completion17 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Model description
- Randomized controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475029
- Sponsor's protocol ID
- 004581
- Other IDs
- 2019-004581-18, 2019
- Acronym
- METAMORF
- Status last verified
- Apr 2023
- First submitted
- 9 Jul 2020
- Last updated
- 13 Sep 2023
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Safety of Intraoperative Methadone in Patients
- ClinicalTrials.gov ID
- NCT04475029
- Acronym / sponsor ID
- METAMORF / 004581
- Conditions
- Pain, Postoperative, Postoperative Complications, Pathologic Processes, Bladder Cancer, Pain, Signs and Symptoms
- Keywords
- morphine, methadone, analgesics, opioids, effect of drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 17 Aug 2023 (actual)
- First posted
- 17 Jul 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 role of a single-dose intraoperative methadone on postoperative pain and opioid consumption in patients undergoing Surgeon Accuracy Robot Assistant cystectomy. A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing robotassisted cystectomy.
Detailed description
During early recovery after surgery, intravenous opioids are typically administered to control the pain, either as intermittent bolus administration by nursing staff or by a patient-controlled analgesia device. Unfortunately, repeated doses or boluses of shorter-acting opioids, such as morphine, oxycodone and fentanyl, result in fluctuating blood concentrations, with the inherent risk of only relatively brief periods of adequate pain relief. Moreover, the use of shorter-acting opioids increases the risk of opioid-associated side effects, such as sedation, nausea and vomiting. An alternative approach to the postoperative use of shorter-acting opioids is therefore called for.
In this respect, methadone is an opioid with unique pharmalogical properties that may be advantageous when applied intraoperatively. A single-dose of this long acting opioid could provide a stable analgesia and potentially reduce the need for shorter-acting opioids
Method:
110 patients will be included in an investigator-initiated, prospective, randomised, double-blind, controlled trial with two arms: intervention arm (methadone 0.15 mg/kg ideal body weight). Control arm (morphine 0.15 mg/kg ideal body weight). The study will be GCP-monitored, and is approved by the Danish Health and Medicines Authority (2020041652) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-275-19).
Hypothesis We hypothesize that a single-dose of intravenous intraoperative methadone is efficient and safe for the treatment of postoperative pain after cystectomy.
Objectives The primary objective is to determine whether a single-dose of intravenous methadone reduces postoperative opioid consumption when compared to morphine. The secondary objectives are to compare the effect and safety of intravenous methadone and morphine on postoperative pain, side effects, patient satisfaction and length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Methadone | Experimental | Drug: MethadoneA 10 ml syringe with 2 mg/ml of methadone will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation. |
| Morphine | Active comparator | Drug: MorphineA 10 ml syringe with 2 mg/ml of morphine will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients (≥18 years) scheduled for elective robot assisted cystectomy.
Key exclusion criteria (18 listed)
- American Society of Anesthesiologists (ASA) physical status IV or V
- Prolonged QTc-interval assessed by electrocardiogram (> 440 milliseconds)
- Existing treatment with a high risk of QTc-interval prolongation
- Allergy to study drugs
- Preoperative daily use of opioids
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 |
|---|---|---|
| MethadoneOne intravenous administration of methadone (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation. | Drug | Methadone |
| MorphineOne intravenous administration of morphine (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation. | Drug | Morphine |
Primary outcome
Opioid consumption (morphine mg equivalents)
Time frame: 3 hours
• Opioid consumption within the first 3 hours after extubation
Opioid consumption (morphine mg equivalents)
Time frame: 24 hours
• Opioid consumption within the first 24 hours after extubation
7 secondary outcomes
Pain intensity
Time frame: within 24 hours
Opioid consumption (morphine mg equivalents)
Time frame: 72 hours
PONV
Time frame: Within 24 hours
Level of sedation
Time frame: 3 hours
Adverse events
Time frame: 6 hours
Patient satisfaction from 0-10.
Time frame: 24 hours
Discharge
Time frame: 6 days
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 13 Sep 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methadone and Morphine in people with Pain, Postoperative and Postoperative Complications, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 18 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 13 Sep 2023. 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 Denmark. 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?
Opioid consumption (morphine mg equivalents) (time frame: 3 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 13 Sep 2023.