Pain Clinical Trial
— METAMORFOfficial title:
Clinical Effectiveness and Safety of Intraoperative Methadone in Patients
Verified date | April 2023 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 114 |
Est. completion date | August 17, 2023 |
Est. primary completion date | August 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | Inclusion Criteria: - All patients (=18 years) scheduled for elective robot assisted cystectomy. Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain intensity | • Pain intensity (NRS, 0-10) at rest and coughing, questionnaires answered by nurse. | 32-72 hours | |
Other | PONV | • Nausea and/or vomiting (PONV) on a 4-point Likert scale (none/mild/moderate/severe). Questionnaires answered by nurse. | 32-72 hours | |
Other | Gastrointestinal function | Gastrointestinal function (flatus, stools) and laxatives ordained. | 6-72 hours | |
Primary | Opioid consumption (morphine mg equivalents) | • Opioid consumption within the first 3 hours after extubation | 3 hours | |
Primary | Opioid consumption (morphine mg equivalents) | • Opioid consumption within the first 24 hours after extubation | 24 hours | |
Secondary | Pain intensity | NRS (0-10) at rest and when coughing. Questionnaires answered by nurse. | within 24 hours | |
Secondary | Opioid consumption (morphine mg equivalents) | • Opioid consumption within the first 72 hours after extubation | 72 hours | |
Secondary | PONV | • Nausea and/or vomiting (PONV) on a 4-point Likert scale (none/mild/moderate/severe). Questionnaires answered by nurse. | Within 24 hours | |
Secondary | Level of sedation | Level of sedation (Ramsey Sedation Score) assessed by PACU nurse. | 3 hours | |
Secondary | Adverse events | Any adverse events registered. | 6 hours | |
Secondary | Patient satisfaction from 0-10. | Patient satisfaction with pain management (NRS 0-10) Questionnaires answered by nurse. | 24 hours | |
Secondary | Discharge | • Time from arrival to discharge from PACU and hospital (hours and minutes) | 6 days |
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