Low-Dose vs High-Dose Epidural Morphine for Post-Cesarean Pain Management

Overseen By Brian Casey, MD

Age: Any Age

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Opioids

Disqualifiers: Preeclampsia, Insulin-treated diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: During hospital stay (up to 2 days)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different doses of morphine administered through an epidural to manage pain after a C-section. Researchers aim to determine if a lower dose (50 mcg) reduces side effects compared to a higher dose (150 mcg) when combined with a QL block, a pain relief technique. Women scheduled for a C-section who prefer this specific pain relief method may be suitable candidates, provided their pregnancy is uncomplicated by conditions such as preeclampsia or insulin-treated diabetes. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants a chance to contribute to pioneering pain management strategies.

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

The trial information does not specify whether you need to stop taking your current medications. However, if you have a history of opioid use disorder, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that epidural morphine is generally safe within certain dose ranges. Typically, individuals new to opioids receive doses between 3.5 to 7.5 mg per day. In this study, the doses are significantly lower: 50 mcg and 150 mcg. These reduced doses aim to minimize side effects.

The 50 mcg dose resembles the amount used for spinal morphine injections, which is effective with fewer side effects.

Even the 150 mcg dose remains much lower than standard epidural doses. Previous studies with higher doses demonstrated good pain relief with manageable side effects like itching or nausea, common with any opioid.

Overall, while this trial is in an early stage, the low doses being tested appear promising for safety. The goal is to reduce side effects while still providing effective pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using different doses of epidural morphine for post-cesarean pain management because it offers a potentially safer and more effective way to manage pain after surgery. Unlike the standard care options, which often include higher doses of opioids and other medications that have significant side effects, the study explores the effects of lower doses like 50 mcg of morphine. This lower dose could reduce the risk of side effects such as nausea and respiratory depression while still effectively managing pain. By comparing it with a higher dose of 150 mcg, researchers aim to find the optimal balance between pain relief and side effect management.

What evidence suggests that this trial's treatments could be effective for post-cesarean pain management?

This trial will compare the effectiveness of low-dose versus high-dose epidural morphine for post-cesarean pain management. Research has shown that epidural morphine effectively manages pain after a cesarean section. Participants in Group B will receive a lower dose of 50 micrograms (mcg), which controls pain well and may lead to fewer side effects. Studies indicate that even small amounts provide good pain relief, helping new mothers move around and care for their babies comfortably. Participants in Group A will receive a higher dose of 150 mcg, which is effective for strong pain control but might cause more side effects. Both low and high doses work well, but the aim is to balance pain relief with minimizing side effects. ^{2 4 5 6 7}

Who Is on the Research Team?

Ayodeji Sanusi, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for women scheduled for cesarean delivery who want a QL block. It's not open to those with insulin-treated diabetes, placental abnormalities, preeclampsia, or a history of opioid use disorder.

Inclusion Criteria

All women presenting for scheduled cesarean delivery who desire a QL block

Exclusion Criteria

Women who have had a pregnancy with preeclampsia complications.

Women who are pregnant and need insulin to control their diabetes are not eligible.

Women who have pregnancy problems related to the placenta are not eligible.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 50mcg or 150mcg of morphine in their neuraxial block during cesarean delivery

During hospital stay (up to 2 days)

In-hospital stay

Follow-up

Participants are monitored for side effects such as nausea, urinary retention, and pruritus, as well as neonatal outcomes

2 days following cesarean delivery

In-hospital assessments

What Are the Treatments Tested in This Trial?

Interventions

• Morphine Sulfate 150mcg
• Morphine Sulfate 50mcg

Trial Overview The study compares two doses of morphine sulfate (50mcg and 150mcg) given epidurally to see if the lower dose can reduce side effects while still providing pain relief after cesarean delivery.

How Is the Trial Designed?

Group I: Group B: 50 mcg morphine Experimental Treatment 1 Intervention

Patients in this group will receive 50mcg of morphine in their neuraxial block

Group II: Group A: 150 mcg morphine Active Control 1 Intervention

Patients in this group will receive 150mcg of morphine in their neuraxial block

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3511948/

Postoperative analgesia with epidural opioids after cesarean ... Epidural analgesia with opioid provides good control of postoperative pain in cesarean section, thereby improving the mother's ability to mobilize and interact ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2058534922000208

Analgesia for Caesarean section This article summarises recent guidance and evidence regarding the provision of optimal analgesia after elective and non-elective CS in contemporary practice.

3. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1126174/full

Efficacy and safety of different doses of epidural morphine ... Multiple studies have demonstrated that analgesia is more effective and some annoying side effects are minimized when opioids are administered ...

4. elsevier.es elsevier.es/es-revista-colombian-journal-anesthesiology-342-articulo-management-post-cesarean-delivery-analgesia-pharmacologic-S2256208717300524

Management of post-cesarean delivery analgesia Multimodal analgesia has proven its effectiveness in postoperative pain control after cesarean delivery, significantly reducing the use of opioids.

5. perioperativemedicinejournal.biomedcentral.com perioperativemedicinejournal.biomedcentral.com/articles/10.1186/s13741-025-00521-z

Dosage of epidural morphine analgesia after lower abdominal ... In this study, we aimed to determine which of three doses within that range (1.5 mg, 3 mg, or 4.5 mg) can provide adequate pain relief.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK541073/

Epidural Morphine - StatPearls - NCBI Bookshelf - NIH The recommended initial epidural dosage for patients not tolerant to opioids ranges from 3.5 to 7.5 mg per day. The recommended starting dosage ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1521689623000046

Intrathecal opioids for the management of post-operative pain Intrathecal opioids are highly effective in the management of post-operative pain. The technique is simple with a very low risk of technical failure or ...