NCT05525923 Personalized Postoperative Pain Management Following Thoracic Surgery in Adults
| NCT ID | NCT05525923 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OpalGenix, Inc |
| Condition | Thoracic Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-11-30 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-11-30 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * \>18 years * 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.)
Contact & Investigator
Kathirvel Subramaniam, MD, MPH
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05525923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Thoracic Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05525923 currently recruiting?
Yes, NCT05525923 is actively recruiting participants. Contact the research team at monroeal@upmc.edu for enrollment information.
Where is the NCT05525923 trial being conducted?
This trial is being conducted at Pittsburgh, United States, Pittsburgh, United States, Pittsburgh, United States, Pittsburgh, United States.
Who is sponsoring the NCT05525923 clinical trial?
NCT05525923 is sponsored by OpalGenix, Inc. The principal investigator is Kathirvel Subramaniam, MD, MPH at University of Pittsburgh. The trial plans to enroll 200 participants.