Spine SurgeryPhase 2/3NCT05693675
Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months
A Phase 2/3 study testing Postoperative methadone and Rescue Analgesia in people with Spine Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility and safety of a clinical protocol based on the administration of intraoperative intravenous methadone followed by a short regimen of oral/IV (if the patient is not able to take oral) methadone following spine surgery and to evaluate if methadone decreases… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spine Surgery
- What is being tested?
- Postoperative methadone and Rescue Analgesia
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 1 Jul 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults undergoing multilevel complex lumbar and/or thoracic spine fusion surgery, including revision surgeries
Who cannot join
- BMI greater than 40
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months - A Pilot Trial.
The purpose of this study is to evaluate the feasibility and safety of a clinical protocol based on the administration of intraoperative intravenous methadone followed by a short regimen of oral/IV (if the patient is not able to take oral) methadone following spine surgery and to evaluate if methadone decreases persistent opioid usage at 3 months in comparison to placebo.
- Conditions
- Spine Surgery
- Being tested
- Postoperative methadone, Postoperative placebo, Rescue Analgesia
- Keywords
- opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative methadoneDrug
Participants will receive intraoperative methadone (0.2 mg/kg ideal body weight intravenously but not exceeding 20mg) followed by oral/IV methadone postoperatively according to the following scheme: A) Opioid naïve patients will receive 5mg twice daily dosage of methadone on postoperative days 1 and 2 followed by 5 mg daily on postoperative days 3, 4, and 5. B) Patients taking opioids preoperatively will continue to receive their regular opioids and additionally receive 5 mg twice a day of methadone on postoperative days 1 and 2, followed by 5 mg per day on days 3, 4 and 5.
Postoperative placeboDrug
Participants will receive intraoperative methadone intravenously 0.2mg/kg followed by oral placebo postoperatively according to the following scheme: Opioid naïve patients and patients taking opioids preoperatively will receive placebo tablets twice daily on day 1 and day 2 and once daily day 3, 4 and 5. Patients taking preoperative opioids will be able to return to their baseline opioids immediately after surgery.
Rescue AnalgesiaDrug
PACU analgesia for both groups will be the usual care regime of fentanyl or hydromorphone bolus as prescribed by the physician anesthesiologist doing the case. All patients receive IV intravenous patient-controlled analgesia and rescue opioids which is usual care for postoperative pain.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative methadone | Experimental | Not described Receives: Drug: Postoperative methadone; Drug: Rescue Analgesia |
| Postoperative placebo | Placebo comparator | Not described Receives: Drug: Postoperative placebo; Drug: Rescue Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study design as assessed by the number of participants for which scheduled postoperative methadone versus placebo were able to be administered according to the scheme described
Measured: Day of discharge (about 6 days after surgery)
Feasibility of study design as assessed by number of participants for which safety was able to be assessed (EKGs)
Measured: postop days 1 and 5
Feasibility of study design as assessed by the number of participants for which safety was able to be assessed (respiratory events)
ability to evaluate adverse respiratory events
Measured: Day of discharge (about 6 days after surgery)
Feasibility of study design as assessed by the number of participants for which postop opioid usage could be surveyed at 3 months
Measured: 3 months after surgery
Secondary outcomes (10)
Number of participants for which opioid usage was able to be collected
Measured: Day of discharge (about 6 days after surgery)
Safety as assessed by the number of patients developing respiratory depression
Saturation of Oxygen(SPO2) less than 85%, Respiratory rate <5 for longer than 3 minutes, ( Khanna et) increased oxygen requirement related to opioid-induced respiratory depression, naloxone use. The SPO2 will be monitored continuously per usual care in post anesthesia care unit (PACU) and every 4 hours in the ward.
Measured: by fifth day of hospital stay
Safety as assessed by the number of patients developing clinically significant corrected QT interval(QTc )prolongation
QTc interval >500ms or >25% increase from baseline; number of patients developing arrhythmias needed treatment
Measured: by fifth day of hospital stay
Safety as assessed by the number of participants with hallucinations
Measured: by fifth day of hospital stay
Safety as assessed by the number of participants with dizziness
Measured: by fifth day of hospital stay
Safety as assessed by the number of participants with Antiemetic use
Measured: by fifth day of hospital stay
Safety as assessed by the number of participants with occurrence of nausea
Measured: by fifth day of hospital stay
Safety as assessed by the number of participants with occurrence of vomiting
Measured: by fifth day of hospital stay
Safety as assessed by the number of participants with occurrence of Ileus or constipation
Measured: by fifth day of hospital stay
Safety as assessed by the number of subjects with persistent opioid use
This is scored from 0(less than once a week) to 4(constantly, a higher number indicating more opioid use)
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Why it stopped: PI left institution; no participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shobana Rajan, The University of Texas Health Science Center, Houston
- Investigators
- Shobana Rajan, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693675
- Sponsor's protocol ID
- HSC-MS-22-0912
- Status last verified
- Mar 2025
- First submitted
- 11 Jan 2023
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months - A Pilot Trial.
- ClinicalTrials.gov ID
- NCT05693675
- Acronym / sponsor ID
- HSC-MS-22-0912
- Conditions
- Spine Surgery
- Keywords
- opioids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution; no participants were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 23 Jan 2023 (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 purpose of this study is to evaluate the feasibility and safety of a clinical protocol based on the administration of intraoperative intravenous methadone followed by a short regimen of oral/IV (if the patient is not able to take oral) methadone following spine surgery and to evaluate if methadone decreases persistent opioid usage at 3 months in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative methadone | Experimental | Drug: Postoperative methadone, Drug: Rescue Analgesia |
| Postoperative placebo | Placebo comparator | Drug: Postoperative placebo, Drug: Rescue Analgesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults undergoing multilevel complex lumbar and/or thoracic spine fusion surgery, including revision surgeries
Key exclusion criteria (1 listed)
- BMI greater than 40
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 |
|---|---|---|
| Postoperative methadoneParticipants will receive intraoperative methadone (0.2 mg/kg ideal body weight intravenously but not exceeding 20mg) followed by oral/IV methadone postoperatively according to the following scheme: A) Opioid naïve patients will receive 5mg twice daily dosage of methadone on postoperative days 1 and 2 followed by 5 mg daily on postoperative days 3, 4, and 5. B) Patients taking opioids preoperatively will continue to receive their regular opioids and additionally receive 5 mg twice a day of methadone on postoperative days 1 and 2, followed by 5 mg per day on days 3, 4 and 5. | Drug | Postoperative methadone |
| Postoperative placeboParticipants will receive intraoperative methadone intravenously 0.2mg/kg followed by oral placebo postoperatively according to the following scheme: Opioid naïve patients and patients taking opioids preoperatively will receive placebo tablets twice daily on day 1 and day 2 and once daily day 3, 4 and 5. Patients taking preoperative opioids will be able to return to their baseline opioids immediately after surgery. | Drug | Postoperative placebo |
| Rescue AnalgesiaPACU analgesia for both groups will be the usual care regime of fentanyl or hydromorphone bolus as prescribed by the physician anesthesiologist doing the case. All patients receive IV intravenous patient-controlled analgesia and rescue opioids which is usual care for postoperative pain. | Drug | Postoperative methadone, Postoperative placebo |
Primary outcome
Feasibility of study design as assessed by the number of participants for which scheduled postoperative methadone versus placebo were able to be administered according to the scheme described
Time frame: Day of discharge (about 6 days after surgery)
Feasibility of study design as assessed by number of participants for which safety was able to be assessed (EKGs)
Time frame: postop days 1 and 5
Feasibility of study design as assessed by the number of participants for which safety was able to be assessed (respiratory events)
Time frame: Day of discharge (about 6 days after surgery)
ability to evaluate adverse respiratory events
Feasibility of study design as assessed by the number of participants for which postop opioid usage could be surveyed at 3 months
Time frame: 3 months after surgery
10 secondary outcomes
Number of participants for which opioid usage was able to be collected
Time frame: Day of discharge (about 6 days after surgery)
Safety as assessed by the number of patients developing respiratory depression
Time frame: by fifth day of hospital stay
Safety as assessed by the number of patients developing clinically significant corrected QT interval(QTc )prolongation
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with hallucinations
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with dizziness
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with Antiemetic use
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with occurrence of nausea
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with occurrence of vomiting
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with occurrence of Ileus or constipation
Time frame: by fifth day of hospital stay
Safety as assessed by the number of subjects with persistent opioid use
Time frame: 3 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- 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. This study is not recruiting at the moment.
Shobana Rajan, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Postoperative methadone and Rescue Analgesia in people with Spine Surgery, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 10 Mar 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study design as assessed by the number of participants for which scheduled postoperative methadone versus placebo were able to be administered according to the scheme described (time frame: Day of discharge (about 6 days after surgery)). The study lists 4 primary outcomes in all. 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 10 Mar 2025.