Personalized Postoperative Pain Management Following Thoracic Surgery in Adults

NCT05525923 | Recruiting

• 1 other identifier: STUDY22070047
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

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

Keywords

Pain Management; Opioid Use

Outcome Measures

Primary Outcomes (3)

• Opioid-related Post-operative nausea and vomiting (PONV)

  PONV is measured with a binary yes/no response

  Post-operative up to 12 months

• Opioid-related sedation

  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.

  Post-operative up to 12 months

• Opioid-related respiratory depression (RD)

  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.

  Post-operative up to 12 months

Secondary Outcomes (7)

• Opioid use

  Pre-operative to post-operative up to 12-months

• Post-operative Pain Scores

  Pre-operative to post-operative up to 12-months

• Length of Hospital Stay

  Post-operative day 1 up to 1-month

• Chronic Post-surgical Pain (CPSP)

  Post-operative up to 12 months

• Length of Prescribed Opioid Usage

  Post-operative up to 12-months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be adults undergoing thoracic surgeries that fit the inclusion criteria. Children will not be included as they are not seen at the specific site institution. Given the nature of the surgical procedure, pregnant women and women that may be pregnant will also not be included in this study population.

You may qualify if:

• \>18 years
• American Society of Anesthesiologists (ASA) Physical Status 1, 2, 3
• Undergoing thoracic surgery (TS; pneumonectomy, lobectomy and segmentectomy)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• OpalGenix, Inc: lead

Study Sites (4)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

UPMC Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

One blood collection will take place at the baseline visit consisting of 1 EDTA tube which will collect approximately 2-3mL. This blood collection will be used for genotyping CYP2D6.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathirvel Subramaniam, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Monroe, MPH, MBA

CONTACT

412-623-6382; monroeal@upmc.edu

Alisha Maslanka, BS

CONTACT

412-864-6779; maslankaaa@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: November 30, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)