Methadone in Cystectomy Patients
Condition: Pain, Postoperative; Postoperative Complications; Pathologic Processes; Bladder Cancer; Pain; Signs and Symptoms; Neurologic Manifestations; Neurologic Symptoms; Side Effect of Drug
MeSH terms: Neurologic Manifestations; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional

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 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.
    

Intervention name(s): Methadone; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): One intravenous administration of methadone (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.; One intravenous administration of morphine (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.
Intervention MeSH terms: Morphine; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: morphine; methadone; analgesics; opioids; effect of drugs