AnalgesiaNCT05612399
Precision Analgesia for Cardiac Surgery
An observational study of Analgesia and Cardiac Surgery, run by Kathirvel Subramaniam at 1 site in United States.
Trial summary
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research. This research focuses on two of the most commonly used oral opioid analgesics, oxycodone, and methadone in elderly adults undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Analgesia, Cardiac Surgery
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 1 May 2027
- Phase
- Observational
- 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 60 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly cardiac surgical patients over 60 years of age Both genders are included All races and ethnic groups undergoing elective open cardiac surgery through midline sternotomy
Who may be able to join
- Elderly cardiac surgical patients over 60 years of age
Who cannot join
- Methadone allergy
- Morbid obesity (BMI >40kg/cm2)
- Severe sleep apnea
- Severe pulmonary disease requiring oxygen therapy
- Preoperative mechanical circulatory support
- Emergency surgery
Show all 9Show fewer
- Liver disease (liver enzymes more than two times normal)
- End-stage renal disease requiring dialysis
- Serum creatinine more than 2.0mg
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
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Kathirvel Subramaniam, MD, MPH, subramaniamk@upmc.edu
Amy Monroe, MPH, MBA, 412-623-6382, monroeal@upmc.edu
About this study
Official title: Precision Perioperative Methadone Use in Adult Cardiac Surgical Patients to Reduce Opioid Use Adverse Effects While Improving Analgesia and Outcomes
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research. This research focuses on two of the most commonly used oral opioid analgesics, oxycodone, and methadone in elderly adults undergoing cardiac surgery.
Read the detailed description
Cardiac surgery patients often experience significant acute postoperative pain, and untreated or undertreated pain has consequences. Each year, 900,000 painful cardiac surgeries occur in the US alone. Pain associated with cardiac surgery results from surgical incision, sternal retraction, internal mammary artery harvesting, saphenous vein removal, placement of mediastinal and chest drains, sternal wires, and release of pro-inflammatory mediators after tissue injury. One study reported that 49%, 62%, and 78% of patients reported severe pain at rest, movement, and coughing, respectively after coronary artery bypass surgery (CABG). Another study showed that 61.4% of patients undergoing cardiac surgery reported moderate to severe pain. Inadequate pain treatment is common in cardiac surgery due to health care providers' fears of causing cardiorespiratory compromise. Poor pain control can trigger sympathoadrenal responses leading to cardiac arrhythmias and myocardial ischemia, restrict mobility to cause venous thrombosis, impair clearance of secretions leading to pulmonary complications such as atelectasis and pneumonia, decrease patient satisfaction and predispose to the development of chronic, persistent surgical pain (CPSP).
Improving clinical practice by shifting paradigms: Our research is transformative and will evolve current reactive clinical practice towards proactive precision methods based on genetic risks for surgical pain and ORADE in elderly vulnerable population. This is the first effort to move in the direction of personalizing perioperative opioid use with precise dosing to improve safety and efficacy in cardiac surgery. Preoperative genotyping-based clinical decisions are expected to support clinical implementation in real-world settings. Importantly, investigators will be able to reach beyond the current best-in-class outcomes with precision multi-dose methadone analgesia based on proactive genetic risk identification to maximize safety and efficacy of opioids in all cardiac surgical patients and positively impact socio-economic outcomes in the future. By addressing these critical barriers, this research will help physicians identify patients at risk and improve the safety and efficacy of opioids and surgical pain management while preventing OD, misuse, overdose, and deaths.
- Conditions
- Analgesia, Cardiac Surgery
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Genetic Factors - Opioid Related Adverse Events (RD)
Respiratory depression will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Measured: Immediately post-surgery during hospital stay
Determine Genetic Factors - Opioid Related Adverse Events (PONV)
Post-operative nausea and vomiting will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Measured: Immediately post-surgery during hospital stay
Determine Genetic Factors - Opioid Related Adverse Events (Excessive Sedation)
Excessive sedation will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Measured: Immediately post-surgery during hospital stay
Determine Genetic Factors - Uncontrolled severe pain
We postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and ORM1 genetic variants identify patients at risk for poor pain relief and ORADE with methadone in the immediate post-surgical period. Pain will be measured by the Numerical Rating Scale (NRS) in which 0 = no pain at all and 10 = worst pain imaginable. This will be self-reported responses by the patient.
Measured: Immediately post-surgery during hospital stay
Secondary outcomes (3)
Opioid use post-operatively
Opioid usage will be recorded via SOAPP-R, a 24-item validated opioid assessment. A score of 18 or higher is considered positive.
Measured: Post-operative Day 5 to 6-months post-operative
Patient-Reported Outcomes Measurement Information System
The PROMIS-29 v2.0 will be collected for this outcome measure. The PROMIS survey is scored by the following T-Score Cut Points: 20-55 = better health, 55-60 = mild, 61-69 = moderate, and 71+ = worse health. The general population mean = 50 (SD = 10).
Measured: Post-operative Day 5 to 6-months post-operative
Incidence of Chronic Persistent Surgical Pain (CPSP)
CPSP will be obtained via patient-self report as yes/no responses for follow-up assessments. This measure will be reported as mean(SD) for positive CPSP subjects.
Measured: Post-operative Day 5 to 6-months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study startOct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathirvel Subramaniam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathirvel Subramaniam, University of Pittsburgh
- Investigators
- Kathirvel Subramaniam, MD, MPH, Principal investigator, University of PittsburghAmy Monroe, MPH, MBA, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612399
- Sponsor's protocol ID
- STUDY22060101
- Status last verified
- Sep 2026
- First submitted
- 3 Nov 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Perioperative Methadone Use in Adult Cardiac Surgical Patients to Reduce Opioid Use Adverse Effects While Improving Analgesia and Outcomes
- ClinicalTrials.gov ID
- NCT05612399
- Acronym / sponsor ID
- STUDY22060101
- Conditions
- Analgesia, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kathirvel SubramaniamUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 10 Nov 2022 (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 proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research. This research focuses on two of the most commonly used oral opioid analgesics, oxycodone, and methadone in elderly adults undergoing cardiac surgery.
Detailed description
Cardiac surgery patients often experience significant acute postoperative pain, and untreated or undertreated pain has consequences. Each year, 900,000 painful cardiac surgeries occur in the US alone. Pain associated with cardiac surgery results from surgical incision, sternal retraction, internal mammary artery harvesting, saphenous vein removal, placement of mediastinal and chest drains, sternal wires, and release of pro-inflammatory mediators after tissue injury. One study reported that 49%, 62%, and 78% of patients reported severe pain at rest, movement, and coughing, respectively after coronary artery bypass surgery (CABG). Another study showed that 61.4% of patients undergoing cardiac surgery reported moderate to severe pain. Inadequate pain treatment is common in cardiac surgery due to health care providers' fears of causing cardiorespiratory compromise. Poor pain control can trigger sympathoadrenal responses leading to cardiac arrhythmias and myocardial ischemia, restrict mobility to cause venous thrombosis, impair clearance of secretions leading to pulmonary complications such as atelectasis and pneumonia, decrease patient satisfaction and predispose to the development of chronic, persistent surgical pain (CPSP).
Improving clinical practice by shifting paradigms: Our research is transformative and will evolve current reactive clinical practice towards proactive precision methods based on genetic risks for surgical pain and ORADE in elderly vulnerable population. This is the first effort to move in the direction of personalizing perioperative opioid use with precise dosing to improve safety and efficacy in cardiac surgery. Preoperative genotyping-based clinical decisions are expected to support clinical implementation in real-world settings. Importantly, investigators will be able to reach beyond the current best-in-class outcomes with precision multi-dose methadone analgesia based on proactive genetic risk identification to maximize safety and efficacy of opioids in all cardiac surgical patients and positively impact socio-economic outcomes in the future. By addressing these critical barriers, this research will help physicians identify patients at risk and improve the safety and efficacy of opioids and surgical pain management while preventing OD, misuse, overdose, and deaths.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly cardiac surgical patients over 60 years of age Both genders are included All races and ethnic groups undergoing elective open cardiac surgery through midline sternotomy
Key inclusion criteria (1 listed)
- Elderly cardiac surgical patients over 60 years of age
Key exclusion criteria (9 listed)
- Methadone allergy
- Morbid obesity (BMI >40kg/cm2)
- Severe sleep apnea
- Severe pulmonary disease requiring oxygen therapy
- Preoperative mechanical circulatory support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine Genetic Factors - Opioid Related Adverse Events (RD)
Time frame: Immediately post-surgery during hospital stay
Respiratory depression will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Determine Genetic Factors - Opioid Related Adverse Events (PONV)
Time frame: Immediately post-surgery during hospital stay
Post-operative nausea and vomiting will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Determine Genetic Factors - Opioid Related Adverse Events (Excessive Sedation)
Time frame: Immediately post-surgery during hospital stay
Excessive sedation will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Determine Genetic Factors - Uncontrolled severe pain
Time frame: Immediately post-surgery during hospital stay
We postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and ORM1 genetic variants identify patients at risk for poor pain relief and ORADE with methadone in the immediate post-surgical period. Pain will be measured by the Numerical Rating Scale (NRS) in which 0 = no pain at all and 10 = worst pain imaginable. This will be self-reported responses by the patient.
3 secondary outcomes
Opioid use post-operatively
Time frame: Post-operative Day 5 to 6-months post-operative
Patient-Reported Outcomes Measurement Information System
Time frame: Post-operative Day 5 to 6-months post-operative
Incidence of Chronic Persistent Surgical Pain (CPSP)
Time frame: Post-operative Day 5 to 6-months post-operative
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 10 Sep 2026.
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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.
Kathirvel Subramaniam, MD, MPH principal investigator
University of Pittsburgh
Amy Monroe, MPH, MBA study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia and Cardiac Surgery, run by Kathirvel Subramaniam 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 9 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: opening soon, as of the sponsor's last update on 10 Sep 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.
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 Alisha Maslanka, BS, CCRC (412-864-6779, maslankaaa@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Genetic Factors - Opioid Related Adverse Events (RD) (time frame: Immediately post-surgery during hospital stay). 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 Sep 2026.