Pain Control Strategies for Opioid Use Disorder

Recruiting at 1 trial location

Overseen By Christopher Fadumiye, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Medical College of Wisconsin

Disqualifiers: Severe aortic stenosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24-36 hours

20 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 6 7 8 9}

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

I have a medical condition like severe allergies or heart issues that prevent me from certain treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three pain control strategies: Postoperative Epidural infusion, Hydromorphone PCA with Morphine, or TAP Block with Exparel

24-36 hours

Follow-up

Participants are monitored for changes in pain assessment scores and symptoms of anxiety, depression, and overall well-being

up to 2 days post-operation

What Are the Treatments Tested in This Trial?

Interventions

• Epidural local anesthetic infusion
• Hydromorphone Patient Controlled Analgesic
• Regional Anesthesia

Trial Overview

The study is testing three pain control methods after childbirth in women with opioid addictions: regional anesthesia, continuous epidural infusion of local anesthetic, and self-administered hydromorphone. It aims to see which method best manages pain and improves mood and well-being.

How Is the Trial Designed?

Group I: Postoperative Epidural infusion for 24-36hrs Active Control 1 Intervention

A subset of participants (n=15) will be divided into three different arms: A.) Postoperative Epidural infusion for 24-36hrs B.) Hydromorphone Patient Controlled Analgesia (PCA) with Preservative free Morphine via epidural for 36hrs C.) Transverse abdominal Plane(TAP) Block with long acting Exparel.

Group II: Transverse abdominal Plane(TAP) Block with long acting Exparel Active Control 1 Intervention

A subset of participants (n=15) will be divided into three different arms: A.) Postoperative Epidural infusion for 24-36hrs B.) Hydromorphone Patient Controlled Analgesia (PCA) with Preservative free Morphine via epidural for 36hrs C.) Transverse abdominal Plane(TAP) Block with long acting Exparel.

Group III: Hydromorphone Patient Controlled Analgesia (PCA),Preservative free Morphine via epidural for 36hrs Active Control 1 Intervention

A subset of participants (n=15) will be divided into three different arms: A.) Postoperative Epidural infusion for 24-36hrs B.) Hydromorphone Patient Controlled Analgesia (PCA) with Preservative free Morphine via epidural for 36hrs C.) Transverse abdominal Plane(TAP) Block with long acting Exparel.

Regional Anesthesia is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Regional Anesthesia for:

• Orthopedic procedures
• Gynecological procedures
• Gastrointestinal procedures
• Chronic pain management

Approved in United States as Regional Anesthesia for:

• Ankle fracture pain control
• Childbirth
• Prostate surgery
• Knee surgery
• Shoulder surgery
• Chronic pain management

Approved in Canada as Regional Anesthesia for:

• Orthopedic procedures
• Gynecological procedures
• Gastrointestinal procedures
• Chronic pain management

Approved in Japan as Regional Anesthesia for:

• Orthopedic procedures
• Gynecological procedures
• Gastrointestinal procedures
• Chronic pain management

Approved in China as Regional Anesthesia for:

• Orthopedic procedures
• Gynecological procedures
• Gastrointestinal procedures
• Chronic pain management

Approved in Switzerland as Regional Anesthesia for:

• Orthopedic procedures
• Gynecological procedures
• Gastrointestinal procedures
• Chronic pain management

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

A study involving 64 healthcare professionals at Black Lion Hospital revealed that while there is a strong belief in the importance of peripheral nerve blocks for pain management, nearly half (48%) do not perform them regularly due to a lack of skills and training.

The study found a significant link between formal training in peripheral nerve blocks and the frequency of their use, suggesting that improving training could enhance their application in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of emergency medicine and orthopaedic physicians' knowledge, attitude, and practice towards the use of peripheral nerve blocks. Zewdie, A., Debebe, F., Azazh, A., et al.[2022]

Peripheral nerve blocks are a safe and effective method for managing early postoperative pain, which is crucial for improving patient outcomes such as satisfaction and reducing hospital costs.

These nerve blocks can serve as an alternative or supplement to traditional pain management, especially for patients who may not tolerate strong narcotics or general anesthesia, including the elderly and those with heart or lung conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Blocks in Foot and Ankle Surgery. Fraser, TW., Doty, JF.[2022]

Peripheral nerve blocks (PNB) can effectively reduce procedural pain and avoid harmful effects of local anesthetics on target tissues, enhancing patient comfort during procedures.

The risks associated with PNBs, such as local nerve damage and systemic toxicity, can be minimized through careful injection techniques and a thorough understanding of the procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional Anesthesia for Orthobiologic Procedures. Khadavi, M., Rehor, D., Roney, A., et al.[2022]

Peripheral nerve blocks are becoming more popular than general anesthesia due to their advantages, but they still carry risks such as overdose and potential nerve damage.

Techniques involving nerve stimulators, anatomical landmarks, and careful selection of needles and anesthetic solutions can enhance the success of these blocks while minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimal use of peripheral nerve blocks]. Bruelle, P., Mangin, R., Lalourcey, L., et al.[2013]

Citations

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Although such exposure may not increase the risk of opioid addiction, it is associated with opioid-induced side effects such as itching.