Personalized Postoperative Pain Management Following Thoracic Surgery in Adults
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorOpalGenix, Inc
About this trial
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
This trial does not accept healthy volunteersQualifiers
>18 years
American Society of Anesthesiologists (ASA) Physical Status 1, 2, 3
Undergoing thoracic surgery (TS; pneumonectomy, lobectomy and segmentectomy)
Disqualifiers
Children (<18 years)
Pregnant women
American Society of Anesthesiologists (ASA) Physical Status 4 or above
Non-English speaking
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Opioid-related Post-operative nausea and vomiting (PONV)
PONV is measured with a binary yes/no response
Time frame
Post-operative up to 12 months2
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.
Time frame
Post-operative up to 12 months3
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.
Time frame
Post-operative up to 12 monthsSecondary outcomes
1
Opioid use
Inpatient total opioid usage
Time frame
Pre-operative to post-operative up to 12-months2
Post-operative Pain Scores
Pain scores will be measured using the patient-reported Numerical Rating Scale (NRS), in which a minimum score of 0 indicates no pain at all and a maximum score of 10 indicates the worst pain imaginable
Time frame
Pre-operative to post-operative up to 12-months3
Length of Hospital Stay
Length of hospital stay will be recorded as the number of days a patient remained in the hospital post-operatively
Time frame
Post-operative day 1 up to 1-month4
Chronic Post-surgical Pain (CPSP)
CPSP is defined as pain that develops after surgical invention and lasts at least 2 months. CPSP will be scored as yes/no.
Time frame
Post-operative up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov