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

Trial Summary

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.

What data supports the effectiveness of this treatment for pain control in opioid use disorder?

Research shows that peripheral nerve blocks, which are part of the treatment, can reduce the need for opioids and provide effective pain relief after surgery. This suggests they might help manage pain in people with opioid use disorder by reducing reliance on opioids. ^{1 2 3 4 5}

Is regional anesthesia generally safe for humans?

Regional anesthesia, including techniques like peripheral nerve blocks and neuraxial anesthesia, is generally considered safe for humans. However, there are some risks such as nerve damage and systemic toxicity, which can be minimized with careful technique and proper understanding. ^{6 7 8 9 10}

How is the treatment of regional anesthesia unique for managing pain in opioid use disorder?

Regional anesthesia, like nerve blocks, is unique because it can provide effective pain relief without the need for opioids, reducing the risk of addiction. This treatment works by numbing specific areas of the body, which helps manage pain directly at the source, unlike systemic pain medications that affect the whole body. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to investigate the efficacy of three different modalities of post-operative pain control in parturient with opioid use disorders. The investigators aim to determine whether the different approach utilized show better outcomes with pain management and if there are any association with reduction of symptoms of anxiety, depression, and overall well-being.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Peripheral nerve blocks. [2005]

2. United States pubmed.ncbi.nlm.nih.gov

Persistent Postoperative Opioid Prescription Fulfillment and Peripheral Nerve Blocks for Ambulatory Shoulder Surgery: A Retrospective Cohort Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Locoregional Anesthesia for Hind Limbs. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Retrospective chart review of perioperative pain management of patients having surgery for closed ankle fractures using peripheral nerve blocks at a level one trauma center. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Effects of Perioperative Peripheral Nerve Blocks on Peri- and Postoperative Opioid Use and Pain Management. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

It's Never Just a Block: An Analysis of Regional Anesthesia Closed Claims. [2020]

7. France pubmed.ncbi.nlm.nih.gov

[Optimal use of peripheral nerve blocks]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Blocks in Foot and Ankle Surgery. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Regional Anesthesia for Orthobiologic Procedures. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A survey of emergency medicine and orthopaedic physicians' knowledge, attitude, and practice towards the use of peripheral nerve blocks. [2022]