Pain Control Strategies for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores different ways to manage pain after surgery for individuals with opioid use disorder. Researchers aim to determine if methods like epidurals, patient-controlled pain relief, or a specific type of nerve block (regional anesthesia) can improve pain management and potentially alleviate anxiety and depression. Participants will be divided into three groups to test these pain relief strategies. Those dealing with substance use disorder and scheduled for surgery might find this trial suitable. As an Early Phase 1 trial, this research focuses on understanding how these pain management methods work in people, offering participants a chance to benefit from innovative treatments.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand how your medications might interact with the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments being tested are generally well-tolerated. For the epidural infusion treatment, studies have found that epidural anesthesia is effective and safe, often providing better pain relief than methods like intravenous (IV) morphine. However, there is a 20-25% chance that the small tube used for infusion might not work properly due to issues like misplacement.
Hydromorphone PCA (patient-controlled analgesia) is also well-researched. It allows patients to manage their own pain relief and has proven more effective than some other methods. While it may not always surpass all other drugs, it is considered safe for short-term use.
The TAP block with Exparel, a long-lasting anesthetic, has been reported as safe, with no major side effects in studies involving hundreds of participants. It provides long-lasting pain relief and helps reduce the need for opioids after surgery.
Overall, these treatments have a proven track record of safety and effectiveness in managing pain.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these pain control strategies for opioid use disorder because they offer unique approaches to managing postoperative pain. The Postoperative Epidural infusion delivers anesthetic directly to the epidural space for 24-36 hours, potentially offering more targeted pain relief compared to systemic opioids. The Hydromorphone Patient Controlled Analgesia (PCA) with Preservative-free Morphine via epidural allows patients to manage their own pain levels with precise dosing, reducing the risk of overuse. The Transverse Abdominal Plane (TAP) Block uses long-acting Exparel to provide localized pain relief, which may minimize the need for systemic opioids and their associated risks. These strategies represent innovative alternatives to traditional opioid-based pain management, focusing on reducing opioid use and enhancing patient comfort.
What evidence suggests that this trial's treatments could be effective for pain control in opioid use disorder?
This trial will compare different pain control strategies for participants with opioid use disorder. Research has shown that using an epidural, which involves a local anesthetic and an opioid, can greatly reduce pain after surgery, especially in the first three days. This method also lessens the need for extra morphine, a common painkiller. In this trial, one group of participants will receive a postoperative epidural infusion for 24-36 hours. Another group will receive hydromorphone PCA (Patient Controlled Analgesia) with preservative-free morphine via epidural for 36 hours. Studies on hydromorphone PCA have shown it manages pain better than regular opioid injections and allows patients more control over their pain relief. A third group will receive TAP blocks with Exparel, a long-lasting pain medication, which have been shown to lower both pain and the need for opioids after surgery. All these treatments aim to manage pain effectively while potentially reducing the use of traditional opioids.16789
Are You a Good Fit for This Trial?
This trial is for new mothers aged 18-35 who are dealing with substance use disorders, specifically opioid addiction. They must not have any allergies to medications or conditions like severe aortic stenosis that would prevent them from receiving an epidural.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of three pain control strategies: Postoperative Epidural infusion, Hydromorphone PCA with Morphine, or TAP Block with Exparel
Follow-up
Participants are monitored for changes in pain assessment scores and symptoms of anxiety, depression, and overall well-being
What Are the Treatments Tested in This Trial?
Interventions
- Epidural local anesthetic infusion
- Hydromorphone Patient Controlled Analgesic
- Regional Anesthesia
Regional Anesthesia is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Orthopedic procedures
- Gynecological procedures
- Gastrointestinal procedures
- Chronic pain management
- Ankle fracture pain control
- Childbirth
- Prostate surgery
- Knee surgery
- Shoulder surgery
- Chronic pain management
- Orthopedic procedures
- Gynecological procedures
- Gastrointestinal procedures
- Chronic pain management
- Orthopedic procedures
- Gynecological procedures
- Gastrointestinal procedures
- Chronic pain management
- Orthopedic procedures
- Gynecological procedures
- Gastrointestinal procedures
- Chronic pain management
- Orthopedic procedures
- Gynecological procedures
- Gastrointestinal procedures
- Chronic pain management
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor