OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults

Launched by OPALGENIX, INC · Jul 6, 2022

Keywords

ClinConnect Summary

The OpalGenix clinical trial is studying how to manage pain after certain back surgeries, specifically lumbar spinal fusion and decompression, in adults. The researchers want to explore how two common pain medications, oxycodone and methadone, work for individuals based on their genetic makeup. By understanding how different genes interact, the goal is to find the safest and most effective doses for managing pain in patients recovering from these surgeries. This study is particularly important because it aims to improve pain management strategies and reduce potential risks associated with opioid use.

To participate in this trial, you must be at least 18 years old and scheduled for lumbar spine surgery due to conditions like spinal stenosis or degeneration. You should also be in good general health (ASA Physical Status 1, 2, or 3). However, if you have certain health issues, such as severe liver or kidney problems, or if you are pregnant or a child, you would not be eligible. Participants can expect to receive personalized pain management based on their genetic profile, which may lead to better outcomes and fewer side effects. This research is crucial for improving pain relief strategies and ensuring patient safety after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \>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
• Exclusion Criteria:
• • Children (\<18 years of age)
• • Pregnant women
• • American Society of Anesthesiologists (ASA) Physical Status 4 or above
• • Non-English speaking
• • Outpatient surgery
• • Concomitant additional surgical procedures
• • Significant liver or kidney dysfunction
• • Significant cardiorespiratory compromise
• • Patients with polysubstance use (e.g., cocaine, marijuana, amphetamine, etc.)