PO Methadone Ortho Outpatient
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKeck School of Medicine of USC
About this trial
The goal of this clinical trial is to learn if oral methadone given before surgery works to minimize post-operative pain and opioid usage. The main questions it aims to answer are:
Does oral methadone improve post-operative pain scores as compared to standard treatment? Does oral methadone lead to reduced use of post-operative and post-discharge opioid usage as compared to the current standard treatment?
Researchers will compare oral methadone to a placebo (a look-alike substance that contains no drug) to assess the questions above.
Participants will:
Receive either oral methadone or a look-alike placebo before surgery Receive standard intraoperative and immediate post-operative pain control at the anesthesiologist's discretion Be asked about their pain levels in the recovery area Keep a diary of pain and opioid usage over the first 2 days after surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
medically optimized participants who will undergo elective arthroscopic knee or hip repair
Disqualifiers
pregnant or breastfeeding, age under 18, history of respiratory compromise, allergy to opioids, recipient of pre-operative nerve block
Trial design
Design model
Parallel
Treatments tested in this trial
Methadone group
Drug5mg PO methadone for participants \<50kg or 10mg PO methadone for participants \>50kg
Placebo
Drugsugar pill that is identical look-alike to study drug
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ControlPlacebo comparator 1 intervention
Group B: InterventionalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post-op opioid usage
opioid usage, as measured in morphine equivalent doses (MED)
Time frame
at Post-Anesthesia Care Unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2Secondary outcomes
1
Post-op Pain Score
pain scores on the visual analog scale (VAS)
Time frame
at Post-Anesthesia Care Unit arrival, post-operative 30 minutes, post-op 60 minutes, post-operative day 1, and post-operative day 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: