Post Operative PainPhase 3NCT07226076
Methadone in TKA for Post-op Pain and Opioid Reduction
A Phase 3 study testing Methadone Hydrochloride in people with Post Operative Pain, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This randomized, double-blind controlled trial investigates whether intraoperative IV methadone (0.15 mg/kg based on ideal body weight) reduces acute postoperative pain and opioid consumption in patients undergoing elective total knee arthroplasty under spinal anesthesia with mepivacaine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Methadone Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2026to 15 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-75 years of age
- Undergoing elective primary total knee arthroplasty with mepivacaine in the spinal anesthesia
Who cannot join
- Allergy to methadone or mepivacaine
- Severe liver disease defined as Child's Pugh Class C
- End stage renal disease requiring dialysis
- Known diagnosis of prolonged QT syndrome
- Currently pregnant
- Unable to provide written, informed consent
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Haley Nitchie, MHA, 843-792-1869, nitchie@musc.edu
About this study
Official title: Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Knee Arthroplasty: a Double-blind Randomized Control Trial
This randomized, double-blind controlled trial investigates whether intraoperative IV methadone (0.15 mg/kg based on ideal body weight) reduces acute postoperative pain and opioid consumption in patients undergoing elective total knee arthroplasty under spinal anesthesia with mepivacaine.
- Conditions
- Post Operative Pain
- Being tested
- Methadone Hydrochloride
- Keywords
- post-operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methadone HydrochlorideDrug
Patients will intraoperatively be administered methadone 0.15mg/kg IV, based on ideal body weight.
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Active comparator | Patients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight. Receives: Drug: Methadone Hydrochloride |
| No Methadone | No intervention | Patients will NOT receive methadone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported pain in the recovery unit after surgery
Patient reported pain on a Visual Analog Scale (VAS) from 0-100mm at approximately 30-60 minutes after arriving to the recovery unit after surgery. A lower pain score means a better outcome.
Measured: up to 24 hours after surgery ends
Secondary outcomes (5)
Opioid Consumption in the recovery unit
Opioid consumption measured in oral morphine milligram equivalents (MMEs) while the patient is in the PACU (Post-Anesthesia Recovery Unit).
Measured: PACU Arrival until PACU Discharge up to 30 days
Time to first opioid rescue dose
Measured from the PACU arrival time, to the time the first opioid rescue dose is given while in the PACU.
Measured: up to 24 hours after surgery ends
Pain scores
Visual Analog Score (VAS) 0-100mm reporting pain at rest, and with movement. A lower pain score means a better outcome.
Measured: PACU, 24 hours, 48 hours, and 72 hours post-operatively.
Postoperative nausea and/or vomiting
Incidence of postoperative nausea and/or vomiting after surgery as reported by the patient.
Measured: PACU through 72 hours post-operatively
Quality of Recovery
Change in quality of recovery score from baseline to 24-hours post-operatively measured using the Quality of Recovery 15 Assessment (QoR-15). This assessment is scored 0-150, with a higher score indicating a better quality of recovery. Each of the 15 questions is on an 11-point numerical rating scale from 0-10, and the selections are added together to result in the total score.
Measured: up to 24-hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start8 Jan 2026
- Primary completion28 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Barrett, Medical University of South Carolina
- Investigators
- William Barrett, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226076
- Sponsor's protocol ID
- Pro00147447
- Status last verified
- Feb 2026
- First submitted
- 6 Nov 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Knee Arthroplasty: a Double-blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07226076
- Acronym / sponsor ID
- Pro00147447
- Conditions
- Post Operative Pain
- Keywords
- post-operative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 10 Nov 2025 (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.
This randomized, double-blind controlled trial investigates whether intraoperative IV methadone (0.15 mg/kg based on ideal body weight) reduces acute postoperative pain and opioid consumption in patients undergoing elective total knee arthroplasty under spinal anesthesia with mepivacaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone | Active comparator | Drug: Methadone HydrochloridePatients will intraoperatively receive methadone 0.15mg/kg IV, based on ideal body weight. |
| No Methadone | No intervention | –Patients will NOT receive methadone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18-75 years of age
- Undergoing elective primary total knee arthroplasty with mepivacaine in the spinal anesthesia
Key exclusion criteria (7 listed)
- Allergy to methadone or mepivacaine
- Severe liver disease defined as Child's Pugh Class C
- End stage renal disease requiring dialysis
- Known diagnosis of prolonged QT syndrome
- Currently pregnant
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 |
|---|---|---|
| Methadone HydrochloridePatients will intraoperatively be administered methadone 0.15mg/kg IV, based on ideal body weight. | Drug | Methadone |
Primary outcome
Patient reported pain in the recovery unit after surgery
Time frame: up to 24 hours after surgery ends
Patient reported pain on a Visual Analog Scale (VAS) from 0-100mm at approximately 30-60 minutes after arriving to the recovery unit after surgery. A lower pain score means a better outcome.
5 secondary outcomes
Opioid Consumption in the recovery unit
Time frame: PACU Arrival until PACU Discharge up to 30 days
Time to first opioid rescue dose
Time frame: up to 24 hours after surgery ends
Pain scores
Time frame: PACU, 24 hours, 48 hours, and 72 hours post-operatively.
Postoperative nausea and/or vomiting
Time frame: PACU through 72 hours post-operatively
Quality of Recovery
Time frame: up to 24-hours post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- 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.
William Barrett, M.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methadone Hydrochloride in people with Post Operative Pain, run by Medical University of South Carolina at 1 site in United States.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Feb 2026. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Nitchie, MHA (843-792-1869, nitchie@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported pain in the recovery unit after surgery (time frame: up to 24 hours after surgery ends). 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 4 Feb 2026.