Intrathecal Hydromorphone vs Morphine for Post-Cesarean Pain in Opioid Use Disorder

Overseen By Amy Penwarden, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: University of North Carolina, Chapel Hill

Must be taking: Buprenorphine

Disqualifiers: Contraindication to spinal anesthesia, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two medications, intrathecal hydromorphone and intrathecal morphine, to determine which better controls pain after a C-section in individuals with opioid use disorder who are taking buprenorphine. Participants will receive one of these medications during spinal anesthesia for the surgery. The trial aims to compare each medication's effectiveness in managing pain, particularly during movement, and assess patient satisfaction with pain relief. This trial suits those scheduled for a C-section, who have opioid use disorder, and are currently taking buprenorphine. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, aiming to understand how they benefit more patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does require participants to be taking buprenorphine.

What is the safety track record for intrathecal hydromorphone and morphine?

Research has shown that both intrathecal hydromorphone and intrathecal morphine effectively manage pain after a cesarean delivery. Administered as part of spinal anesthesia, these medications help control pain. Studies have demonstrated that these treatments can be safely combined with other pain relief methods to enhance outcomes.

Intrathecal morphine and hydromorphone have been tested and proven effective for pain relief. They are used in specific doses, with a known effective ratio of 2:1 for morphine to hydromorphone, ensuring adequate pain management.

Safety data from previous research indicates that these treatments are generally well-tolerated, with no major safety concerns reported. However, like any treatment, some side effects may occur, but these are usually manageable.

As this is a phase 4 trial, the treatment is already approved, and its safety is well-established for other uses. This trial aims to gather more information on its use for a specific group of patients, such as those with opioid use disorder. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about intrathecal hydromorphone for post-cesarean pain in individuals with opioid use disorder because it offers a new approach compared to the standard intrathecal morphine. Unlike morphine, hydromorphone is administered in a smaller dose, which might reduce side effects while still providing effective pain relief. This treatment is also unique because it includes a preservative-free formulation, ensuring safety for spinal administration. Additionally, by directly targeting the spinal cord, intrathecal hydromorphone may offer rapid and targeted pain control, which is crucial for new mothers in recovery from opioid use disorder.

What evidence suggests that this trial's treatments could be effective for post-cesarean pain in patients with opioid use disorder?

This trial will compare intrathecal hydromorphone with intrathecal morphine for managing post-cesarean pain in women with opioid use disorder. Studies have shown that intrathecal morphine effectively relieves pain after a cesarean section. This method is well-established and benefits many women post-surgery. Research indicates that intrathecal hydromorphone is gaining popularity for this purpose. Hydromorphone might offer better pain relief but can sometimes cause more nausea. The trial tests both drugs to determine which works best for women with opioid use disorder who are taking buprenorphine. The results could improve pain management options for these patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Amy Penwarden, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for patients with Opioid Use Disorder (OUD) who are taking buprenorphine and undergoing cesarean delivery under spinal anesthesia. They should be in good or stable condition (ASA Physical Status II or III). Those allergic to acetaminophen, ibuprofen, or with contraindications to spinal anesthesia cannot participate.

Inclusion Criteria

Patients must have a diagnosis of Opioid Use Disorder (OUD)

I am currently taking buprenorphine.

I am having a C-section with spinal anesthesia and my health is moderately to severely impaired.

Exclusion Criteria

I cannot have spinal anesthesia due to health reasons.

I am in labor and have an epidural that will be used for my cesarean delivery.

I am allergic or intolerant to acetaminophen or ibuprofen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either intrathecal hydromorphone or morphine during cesarean delivery under spinal anesthesia

1 day

1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for pain scores, satisfaction, and opioid side effects at 6, 12, and 24 hours postoperatively

24 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and opioid consumption

36 hours

What Are the Treatments Tested in This Trial?

Interventions

• Intrathecal Hydromorphone
• Intrathecal Morphine

Trial Overview The study compares intrathecal hydromorphone versus intrathecal morphine for post-cesarean pain management in OUD patients on buprenorphine. It's a double-blind trial where participants receive either drug along with standard pain control measures and are monitored for 36 hours post-surgery.

How Is the Trial Designed?

Group I: Intrathecal Hydromorphone Experimental Treatment 3 Interventions

Participants in this arm will receive intrathecal 100 mcg of preservative free hydromorphone (0.1mL) with 0.3mL of saline added for a total volume of 0.4mL with administration of 0.75% bupivacaine in 8.25% dextrose (dose determined by patient weight, height, gestational age) and 15 mcg fentanyl

Group II: Intrathecal Morphine Active Control 3 Interventions

Participants in this arm will receive intrathecal 200 mcg of preservative free morphine (0.4mL) with administration of 0.75% bupivacaine in 8.25% dextrose (dose determined by patient weight, height, gestational age) and 15 mcg fentanyl

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

Intrathecal hydromorphone provided superior pain relief with fewer side effects compared to intrathecal morphine in a 22-year-old woman undergoing a cesarean delivery, suggesting it may be a better alternative for patients with opioid allergies.

This case report highlights the potential of intrathecal hydromorphone as a safe and effective option for postoperative pain management, warranting further research to confirm its benefits over traditional opioids like morphine and fentanyl.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathecal hydromorphone for cesarean delivery: in search of improved postoperative pain management: a case report. Rauch, E.[2013]

In a study of 114 women undergoing elective Cesarean delivery, intrathecal hydromorphone (0.04 mg) provided similar analgesia and opioid-related side effects compared to intrathecal morphine (0.1 mg).

There were no significant differences in the frequency of complications like nausea or pruritus, total opioid consumption, or pain scores between the two groups within 24 hours post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesia after Cesarean delivery: a retrospective comparison of intrathecal hydromorphone and morphine. Beatty, NC., Arendt, KW., Niesen, AD., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06784180

Study Details | NCT06784180 | Intrathecal Hydromorphone ... This is a single center, double-blind, randomized trial to compare the effects of intrathecal hydromorphone versus intrathecal morphine to treat post ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8754417/

Intrathecal morphine versus intrathecal hydromorphone for ... The effectiveness of intrathecal morphine for post-cesarean analgesia is well-established, and the use of intrathecal hydromorphone is growing.

3. asra.com asra.com/news-publications/asra-newsletter/newsletter-item/asra-news/2023/05/12/development-of-a-multimodal-pain-management-protocol-and-inpatient-consult-service-for-parturients-diagnosed-with-opioid-use-disorder-(oud)-undergoing-cesarean-delivery

Development of a Multimodal Pain Management Protocol ... Although we've optimized post-cesarean analgesia for most women, women on buprenorphine continue to experience severe pain after cesarean ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959289X16302199

Neuraxial opioids for post-cesarean delivery analgesia Analgesia was superior with hydromorphone although nausea and vomiting were more frequent. In a recent retrospective analysis by Beatty et al. there was no ...

5. ajog.org ajog.org/article/S0002-93782100999-6/fulltext

A comparison of acute pain management strategies after ... The primary outcome was postoperative opioid use defined as morphine milligram equivalents in the first 48 hours. The secondary outcomes included serial pain ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20118037

Intrathecal Opioids for Pain Control after Cesarean Delivery Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve pain control after cesarean delivery.

7. journals.lww.com journals.lww.com/md-journal/fulltext/2022/12020/analgesic_effect_of_butorphanol_tartrate_combined.111.aspx

Analgesic effect of butorphanol tartrate combined with... The ratio of intrathecal morphine to intrathecal hydromorphone for effective post cesarean analgesia is 2:1 and the analgesic effect of ...