Recruiting

Pain Management

Sponsor:

OpalGenix, Inc

Code:

NCT05525923

Conditions

Thoracic Surgery

Pneumonectomy

Lobectomy

Segmentectomy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Thoracic Surgery

Pneumonectomy

Lobectomy

Segmentectomy

Study ID

NCT05525923

Start date

Nov 30, 2023

Status verified date

Apr, 2025

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Opioid-related Post-operative nausea and vomiting (PONV) [ Time Frame: Post-operative up to 12 months ]
  • Opioid-related sedation [ Time Frame: Post-operative up to 12 months ]
  • Opioid-related respiratory depression (RD) [ Time Frame: Post-operative up to 12 months ]

Central Contacts and Locations

Central contacts

Locations

UPMC Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Kathirvel Subramaniam, MD, MPH

subramaniamk@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

UPMC Mercy Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Kathirvel Subramaniam, MD

subramaniamk@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

Principal Investigator:

Kathirvel Subramaniam, MD

UPMC Shadyside Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Kathirvel Subramaniam, MD

subramaniamk@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

Principal Investigator:

Kathirvel Subramaniam, MD

UPMC Passavant Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Kathirvel Subramaniam, MD

subramaniamk@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

Principal Investigator:

Kathirvel Subramaniam, MD

More Information

Sponsor

OpalGenix, Inc

Last update posted

May 1, 2025

Last verified

Apr, 2025

Keywords

  • Pain Management
  • Opioid Use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OpalGenix, Inc on 2025-05-01.