Ireland
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Recruiting Observational

Personalized Postoperative Pain Management Following Thoracic Surgery in Adults

NCT05525923 · tracked via the Priya Life Science USA tracker
Sponsor
OpalGenix, Inc
Phase
Observational
Started
2023-11-30
Last updated
2025-05-01

Condition(s) studied

Thoracic SurgeryPneumonectomyLobectomySegmentectomy

Study 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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.)

Primary outcome measure(s)

  • Opioid-related Post-operative nausea and vomiting (PONV) — Post-operative up to 12 months
    PONV is measured with a binary yes/no response
  • Opioid-related sedation — 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) — 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.

Trial sites (4)

FacilityCityRegionStatus
UPMC Presbyterian Hospital Pittsburgh Pennsylvania Recruiting
UPMC Mercy Hospital Pittsburgh Pennsylvania Recruiting
UPMC Shadyside Hospital Pittsburgh Pennsylvania Recruiting
UPMC Passavant Hospital Pittsburgh Pennsylvania Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05525923 on ClinicalTrials.gov ↗ ← All trials in the USA