OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression 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 lumbar spinal fusion and decompression surgery. Genetic signature and combinatorial pharmacogenetic approaches perform better than single-gene associations. This innovative translational research will for the first time evaluate simultaneously the effects of multiple genes and interactions on oxycodone and methadone's pharmacokinetics and optimal clinical dosing and on its safety and efficacy in the highly vulnerable pediatric population. This research's multigenetic signature findings can be easily extrapolated to adults undergoing surgery or using oxycodone and/or methadone for chronic and cancer pain and in identifying opioid abusers at risk of severe respiratory depression and death.
When methadone is given in addition to oxycodone for inpatient pectus excavatum repair and idiopathic scoliosis spinal fusions according to new departmental protocols, methadone pharmacokinetics and pharmacodynamics will also be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>18 years of age
American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3
Undergoing lumbar spine surgeries (lumbar spine decompression, multilevel posterior spine fusion, internal fixation or a combination) for degenerative lumbar spine and lumbar spinal stenosis and requiring opioids for perioperative pain management
Disqualifiers
Children (<18 years of age)
Pregnant women
American Society of Anesthesiologists (ASA) Physical Status 4 or above
Non-English speaking
Trial population
Study population will be adults undergoing lumbar spine 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