- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00892606
Methadone Versus Morphine for Orthopedic Surgery Patients
Effectiveness of Pre-Operative Methadone Versus Morphine for Post-Operative Analgesia in Orthopedic Surgery Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will receive 1-4 mg midazolam before being transferred to the operating room. All patients will receive standard ASA monitoring. In the operating room, the anesthesiologist will open a randomization envelope to determine patient group assignment (see below). Patients will be anesthetized with 0.2 mg/kg ketamine, 2 µg/kg fentanyl and propofol or etomidate IV. Muscle relaxant of the anesthesiologist's choice will be given and the patient will be intubated. After intubation, the computer-generated randomization codes stored in opaque envelopes will be opened. The patients will be randomized to one of two groups:
- Methadone group: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
- Control group: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
The unblinded investigator will draw the drug and dilute to a total volume of 10 cc. This syringe will be handed to the anesthesia provider, who will administer the medication after induction. They will be maintained with oxygen, air and an inhalational agent of anesthesiologist's choice, targeted at BIS between 40 and 60. Additional analgesia will be provided with fentanyl in 50 µg increments as required throughout surgery. At the end of surgery the neuromuscular block will be reversed and patients will breathe spontaneously. Fentanyl will be titrated to maintain a respiratory rate of 12-15 breaths per minute to obtain an O2 saturation > 95% and the other extubation criteria are met before tracheal extubation . The intraoperative use of narcotics, sedatives and anesthetic drugs will be noted. The type of surgery, the duration of surgery and use of additional analgesics and antiemetics will be noted.
An investigator blinded to randomization will track the patients in the PACU. If rescue medication is necessary, morphine IV will be given in 2-4 mg increments up to a total of 20 mg. If the patients continue to report pain (VAS > 4), IV hydromorphone will be given in 0.5 mg dose every 10-15 minutes until the patient has adequate analgesia (VAS < 4), as decided by the PACU nurse.
Patients will receive morphine patient-controlled analgesia (PCA) for pain relief as the primary analgesic. Percocet (Acetaminophen/Oxycodone 325 mg/5 mg) or Lortab (Acetaminophen/Hydrocodone 325/5 mg) will be prescribed as needed to maintain VRS < 4.
In the PACU, vital signs including respiratory rate, heart rate, non-invasive blood pressure, sedation score and oxygen saturation will be recorded every 15 minutes. VAS scores for pain will be obtained from the patient every 15 minutes until the patient is discharged to the floor. VAS (visual analog scale) is a 100-mm scale where 0 = no pain and 100 = worst pain imaginable. The investigator will record sedation scores every 15 minutes using the following scale until patient is discharged to the floor:
0-Patient is fully alert
- Patient has intermittent sedation
- Patient sedated but responsive to verbal stimuli
- Patient unresponsive to verbal stimuli
Patients will be seen at 8 am and 4 pm on the following day and will be contacted at home or in the hospital on POD 2 and 3 for information regarding pain scores and analgesic requirement. The initial dose of rescue analgesic and time it is given will be recorded. VAS at rest and on movement will be recorded, when the patients are seen or VRS will be recorded via phone contact. Morphine or other analgesics required during the first 24 and 48 hours after surgery, and times to first ambulation, first fluid, solid and flatus will be recorded, as will incidence and severity of postoperative nausea and vomiting be recorded.
Our primary outcome will be opioid consumption during the 48 hours after surgery. All analgesics consumed will be converted to morphine equivalent.
The secondary outcomes will be
- Overall rescue analgesic, converted into equipotent doses compared between the two groups
- Side effects with special attention paid to respiratory rate and possible respiratory depression, and PONV
- Visual pain score at 48 h post-op.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- University of Louisville Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I-III
- Ages 18-65 years
- Presenting for lower extremity orthopedic surgery involving fracture of long bones at University of Louisville Hospital
- Surgery expected to last more than one hour
- Patient expected to have moderate to severe post-operative pain
- Patient refused regional anesthesia or has a contraindication to regional anesthesia
Exclusion Criteria:
- Any known contraindications to methadone including hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
- Difficulty or inability to understand the study or protocol
- Known renal or hepatic dysfunction
- BMI> 35
- Known respiratory or cardiovascular problems, such as obstructive sleep apnea or oxygen saturation of less than 92% on room air
- Taking any of the known drugs that induce or inhibit the cytochrome p450 enzyme systems. Common examples of these drugs are antifungal, antiretroviral, barbiturates, dexamethasone, and macrolide antibiotics.
- Pregnancy
- Taking preoperative opioids for more than 2 weeks before the surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Methadone
Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine and 0.2 mg/kg of methadone IV with induction of general anesthesia.
|
Patients will receive 0.2 mg/kg of methadone IV immediately after intubation
Other Names:
|
Active Comparator: Control
Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg morphine (standard of care)
|
Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Consumption During the 48 Hours After Surgery
Time Frame: 48 hours
|
The amount of opioid required for postoperative pain relief
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Post Operative Nausea and Vomiting
Time Frame: 48 hours
|
rates subjects experienced PONV
|
48 hours
|
Visual Pain Score
Time Frame: 48 hours
|
Patients rated their pain with the numerical VPS from 0 to 10, with 10 being the worst pain possible and 0 being no pain
|
48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anupama Wadhwa, MD, University of Louisville
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Morphine
- Methadone
Other Study ID Numbers
- UofL IRB # 08.0200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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