NCT05525923 · OpalGenix, Inc
Personalized Postoperative Pain Management Following Thoracic Surgery in Adults
What this study is about
The proposed research is an important extension of an ongoing perioperative personalized analgesia and given through a vein (IV) opioid pharmacogenetic research. This research focuses on two of the most commonly used taken by mouth opioid analgesics, oxycodone, and methadone, in adults following thoracic surgery.
View original scientific description
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 adults following thoracic surgery. Major inpatient thoracic surgeries (TS) for lung disease are common and extremely painful surgeries and are associated with sever post-surgical pain, high incidence of chronic post-surgical pain (CPSP), excess opioid use, costly immediate postoperative opioid adverse events (AEs), and long hospital stays. This study is aiming to develop proactive risk prediction algorithms for precision surgical pain relief in adult TS patients through comparison of actual clinical outcomes with standard of care to predicted outcomes based on personalized risk assessments.
Primary outcome measures
Opioid-related Post-operative nausea and vomiting (PONV)
Time frame: Post-operative up to 12 months
PONV is measured with a binary yes/no response
Opioid-related sedation
Time frame: Post-operative up to 12 months
Sedation will be measured using the Riker Sedation Scale. The minimum score of 1 categorizes the patient as being unarousable, while the maximum score of 7 categorizes the patient as being dangerous agitation.
Opioid-related respiratory depression (RD)
Time frame: Post-operative up to 12 months
Respiratory depression is defined as abnormally slow respiratory rate which is below 12 breaths per minute. This will be measured with a binary yes/no response pulled from the electronic medical records.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- American Society of Anesthesiologists (ASA) Physical Status 1, 2, 3
- Undergoing thoracic surgery (TS; pneumonectomy, lobectomy and segmentectomy)
Exclusion criteria
- Children (\<18 years)
- Pregnant women
- American Society of Anesthesiologists (ASA) Physical Status 4 or above
- Non-English speaking
- Outpatient surgery
- Concomitant additional surgical procedures
- Significant liver and kidney dysfunction
- Significant cardiorespiratory compromise
- Patients with polysubstance use (e.g., cocaine, marijuana, amphetamine, etc.)
Where
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2025 · Source of record for eligibility and locations