Pain, PostoperativePhase 4NCT07517679
Methadone for Post-operative Spine Surgery
A Phase 4 study testing Methadone in people with Pain, Postoperative, run by Brandon Knopp at 1 site in United States.
Trial summary
The goal of this prospective cohort study is to evaluate the clinical effects of post-induction methadone on perioperative pain control, opioid requirements, and recovery outcomes in adult patients undergoing elective spine surgery, with the goal of improving postoperative analgesia and enhancing recovery efficiency. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to Apr 2027
- Phase
- Phase 4
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective spine surgery (e.g., fusion, decompression)
- Expected postoperative inpatient admission
- Able to provide informed consent
- Patients with opioid use disorder (OUD) may be included if on stable maintenance therapy
Who cannot join
- Use of regional or neuraxial anesthesia
- Contraindication to methadone use (e.g., prolonged QTc, allergy, severe hepatic disease)
- Cognitive impairment precluding consent or accurate pain scoring
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
University of Kentucky
Lexington, Kentucky, 40536
Brandon Knopp, MD, 859-218-0097, bwkn222@uky.edu
About this study
Official title: Effect of Post-Induction Methadone on Postoperative Pain, Opioid Use, and Recovery in Spine Surgery
The goal of this prospective cohort study is to evaluate the clinical effects of post-induction methadone on perioperative pain control, opioid requirements, and recovery outcomes in adult patients undergoing elective spine surgery, with the goal of improving postoperative analgesia and enhancing recovery efficiency. The main questions it aims to answer are the perioperative pain control and opioid requirements between the two groups.
Post-induction methadone can offer equivalent or improved pain control following major spine procedures and reduce intra- and postoperative opioid requirements, improve perioperative pain control and shorten PACU stay.
Read more
Researchers will compare perioperative opioid use (morphine equivalents (ME), during the intraoperative and postoperative periods (PACU and 24-hour totals) between the standard intraoperative opioid regimen group and the methadone group.
Patients will be randomized preoperatively to one of two groups: (both groups will receive additional multimodal pain control including opioids, not including methadone, as needed) Standard intraoperative opioid regimen (control) Methadone 0.2 mg/kg (max 20 mg)
If the patient is in the methadone group, the patient will receive a predetermined dose of Methadone (0.2mg/kg) intravenously after induction (they are given medications to sleep for surgery). They will proceed with surgery, and all patients will receive standard of care management regardless of whether they receive Methadone or not. Following the surgery, all study participants will be asked at set times about their pain level and, 24 hours after the surgery, will be asked if they are satisfied with their pain management for the surgery. Data regarding their clinical progression and pain control/pain medication requirements will be collected for the duration of the hospitalization.
- Conditions
- Pain, Postoperative
- Being tested
- Methadone, Standard of care
- Keywords
- methadone, opioids, spine surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Methadone 0.2 mg/kg (max 20 mg)
Standard of careDrug
Standard intraoperative opioid regimen (control)
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Experimental | Not described Receives: Drug: Methadone |
| Standard of care | Active comparator | Not described Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Opioid use in morphine equivalents (ME)
perioperative opioid use (morphine equivalents (ME): intraoperative, PACU, and 72-hour totals)
Measured: Perioperative until 72 hours postoperative
Secondary outcomes (6)
Change in numeric rating scale (NRS) pain scores
Pain scores recorded in the electronic medical record (EMR) using the NRS scale 0-10. A higher score indicates greater pain level. Will track scores over first 24 hours following surgery completion (as determined by PACU arrival)
Measured: PACU arrival to 24 hours postoperative
Time in PACU
Will measure duration of time patient spends in the PACU (measured in hours)
Measured: PACU arrival to PACU discharge (determined by time of PACU discharge note entry). Assess up to 24 hours postoperatively.
Hospital Length of Stay
Duration of time the patient spends in the hospital. Measured in days
Measured: Hospital admission to hospital discharge. Measured in days and determined as the time from admission for surgery to hospital discharge. Assess up to 30 days postoperatively
Incidence of respiratory depression
The incidence of respiratory depression would be defined by any of the following:
- respiratory rate < 10 breaths/min for >5 min
- SpO₂ < 90% for >5 min (SpO₂ <88% if history of COPD)
- PaCO₂ > 50 mmHg AND increased more than 20% of baseline (if baseline known)
- Naloxone use postoperatively
The following events will be documented in the electronic medical record (EMR) and study personnel will chart review for documented incidence of the criteria above and report findings. Will be reported as a "yes" or "no".
Measured: Measured from time of PACU admission until 72 hours postoperatively.
Incidence of Postoperative nausea and vomiting
Incidence of postoperative nausea or vomiting will be recorded in the electronic medical record (EMR) and study personnel will chart review for documented incidence of postoperative nausea or vomiting during the first 72 hours postoperatively.
Measured: Assessed postoperatively up to 72 hours after documented PACU admission time
Patient Satisfaction
Patient satisfaction survey will be administered by study staff 24 hours postoperatively to measure the patient satisfaction of their postoperative pain management. The survey will measure the following over the 24 postoperatively: the patients pain level on a scale from 1-10, their pain control adequacy from very poorly to very well, functional impact on getting out of bed, walking, deep breathing/coughing, physical therapy, sleeping or none, side effects of opioids including: nausea, vomiting, itching, constipation, excessive sleepiness, dizziness, or confusion, and their satisfaction level of pain management from very dissatisfied to very satisfied.
Measured: Postoperative until 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start10 Jun 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brandon Knopp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brandon Knopp, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517679
- Sponsor's protocol ID
- 111197
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Post-Induction Methadone on Postoperative Pain, Opioid Use, and Recovery in Spine Surgery
- ClinicalTrials.gov ID
- NCT07517679
- Acronym / sponsor ID
- 111197
- Conditions
- Pain, Postoperative
- Keywords
- methadone, opioids, spine surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brandon KnoppUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Apr 2026 (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.
The goal of this prospective cohort study is to evaluate the clinical effects of post-induction methadone on perioperative pain control, opioid requirements, and recovery outcomes in adult patients undergoing elective spine surgery, with the goal of improving postoperative analgesia and enhancing recovery efficiency. The main questions it aims to answer are the perioperative pain control and opioid requirements between the two groups.
Post-induction methadone can offer equivalent or improved pain control following major spine procedures and reduce intra- and postoperative opioid requirements, improve perioperative pain control and shorten PACU stay.
Researchers will compare perioperative opioid use (morphine equivalents (ME), during the intraoperative and postoperative periods (PACU and 24-hour totals) between the standard intraoperative opioid regimen group and the methadone group.
Patients will be randomized preoperatively to one of two groups: (both groups will receive additional multimodal pain control including opioids, not including methadone, as needed) Standard intraoperative opioid regimen (control) Methadone 0.2 mg/kg (max 20 mg)
If the patient is in the methadone group, the patient will receive a predetermined dose of Methadone (0.2mg/kg) intravenously after induction (they are given medications to sleep for surgery). They will proceed with surgery, and all patients will receive standard of care management regardless of whether they receive Methadone or not. Following the surgery, all study participants will be asked at set times about their pain level and, 24 hours after the surgery, will be asked if they are satisfied with their pain management for the surgery. Data regarding their clinical progression and pain control/pain medication requirements will be collected for the duration of the hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone | Experimental | Drug: Methadone |
| Standard of care | Active comparator | Drug: Standard of care |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing elective spine surgery (e.g., fusion, decompression)
- Expected postoperative inpatient admission
- Able to provide informed consent
- Patients with opioid use disorder (OUD) may be included if on stable maintenance therapy
Key exclusion criteria (3 listed)
- Use of regional or neuraxial anesthesia
- Contraindication to methadone use (e.g., prolonged QTc, allergy, severe hepatic disease)
- Cognitive impairment precluding consent or accurate pain scoring
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 |
|---|---|---|
| MethadoneMethadone 0.2 mg/kg (max 20 mg) | Drug | Methadone |
| Standard of careStandard intraoperative opioid regimen (control) | Drug | Standard of care |
Primary outcome
Perioperative Opioid use in morphine equivalents (ME)
Time frame: Perioperative until 72 hours postoperative
perioperative opioid use (morphine equivalents (ME): intraoperative, PACU, and 72-hour totals)
6 secondary outcomes
Change in numeric rating scale (NRS) pain scores
Time frame: PACU arrival to 24 hours postoperative
Time in PACU
Time frame: PACU arrival to PACU discharge (determined by time of PACU discharge note entry). Assess up to 24 hours postoperatively.
Hospital Length of Stay
Time frame: Hospital admission to hospital discharge. Measured in days and determined as the time from admission for surgery to hospital discharge. Assess up to 30 days postoperatively
Incidence of respiratory depression
Time frame: Measured from time of PACU admission until 72 hours postoperatively.
Incidence of Postoperative nausea and vomiting
Time frame: Assessed postoperatively up to 72 hours after documented PACU admission time
Patient Satisfaction
Time frame: Postoperative until 24 hours postoperative
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 20 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methadone in people with Pain, Postoperative, run by Brandon Knopp 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 4 inclusion and 3 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 20 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Opioid use in morphine equivalents (ME) (time frame: Perioperative until 72 hours postoperative). 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 20 Jul 2026.