180 Participants NeededMy employer runs this trial

Buprenorphine for Post-C-Section Pain

DK
Overseen ByDaniel Katz
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different pain relief methods for individuals undergoing a planned C-section. Researchers aim to determine whether buprenorphine (an opioid pain medication) or morphine more effectively manages post-surgery pain. Participants will be randomly assigned to receive one of these medications as part of their spinal anesthesia. The trial seeks individuals scheduled for a single baby, full-term C-section who do not have allergies to the medications or chronic pain issues. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand its benefits for more patients.

What is the safety track record for these treatments?

Research has shown that buprenorphine is safe for women undergoing C-sections. Studies have found that women can maintain their usual dose of buprenorphine during their hospital stay for delivery without major issues. Evidence also suggests that buprenorphine is as effective as other treatments for managing post-C-section pain.

Morphine, a well-known pain reliever, is often used after surgeries, including C-sections. While effective, it may cause side effects like nausea and drowsiness, which are generally known and manageable.

Both treatments have been used successfully in medical settings, indicating they are generally well-tolerated.12345

Why are researchers enthusiastic about this study treatment?

Buprenorphine is unique because it offers a new approach to managing post-C-section pain by acting on the brain's opioid receptors differently than traditional opioids like morphine. Unlike morphine, which can lead to higher risks of respiratory depression and addiction, buprenorphine has a ceiling effect on its respiratory depression potential, making it potentially safer for new mothers. Researchers are excited about buprenorphine because it could provide effective pain relief with fewer side effects, leading to a better recovery experience for women after a C-section.

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

Research has shown that buprenorphine can help manage various types of pain. Known for reducing pain perception, it has been used in different pain treatments. This medication works by attaching to specific brain receptors, blocking pain messages. While it has been used for other pain issues, its effectiveness for post-surgical pain, such as after a C-section, is under study. In this trial, participants will receive either buprenorphine or morphine, a well-known painkiller, to compare their effectiveness in relieving pain and potentially reducing side effects.678910

Who Is on the Research Team?

DK

Daniel Katz

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for pregnant individuals scheduled for a planned (elective) C-section who need pain relief after surgery. People with certain medical conditions or other reasons that could affect safety or results may not be able to join.

Inclusion Criteria

Presenting for singleton elective cesarean delivery at term gestation

Exclusion Criteria

Allergy to buprenorphine or morphine
I am currently taking opioid pain medications.
I have a chronic pain condition.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either intrathecal buprenorphine or morphine for postcesarean analgesia

72 hours
In-hospital stay

Follow-up

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

3 days
Daily assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Buprenorphine
  • Morphine

Trial Overview

The study compares two types of spinal pain medications—buprenorphine and morphine—given during C-section. Participants are randomly assigned to receive one of these drugs to see which works better for post-surgery pain control.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BuprenorphineExperimental Treatment1 Intervention
Group II: MorphineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Citations

1.

en.wikipedia.org

en.wikipedia.org/wiki/Pain

Pain

Simple over-the-counter pain medications are useful in 20% to 70% of cases of common acute pain, such as post-tooth extraction pain. ... Psychological factors ...

A novel potential strategy for the treatment of... : Pain - Browse

By contrast, HMWH has been shown to play a role in antinociception. The authors have previously shown that HMWH is effective at attenuating inflammatory pain in ...

3.

medlineplus.gov

medlineplus.gov/pain.html

Pain

Environmental factors and psychological factors such as stress and beliefs about pain may affect the way you feel pain and respond to treatment.

PAIN

Moreover, 61% reported that pain distribution should be routinely considered in pain management alongside intensity. Results suggest that pain distribution ...

Pain Management Resource Center

Chronic pain affects an estimated 86 million American adults to some degree. Here you'll find the latest pain management information including treatments, ...

Pain Management After Cesarean Delivery Among Women ...

This study provides empirical evidence supporting continued buprenorphine treatment for women with OUD throughout the perioperative period of a cesarean ...

Post-cesarean delivery pain. Management of the opioid ...

Antenatal counseling and a comprehensive peripartum anesthetic plan are key. · Maintain usual buprenorphine or methadone doses in the peripartum period. · Avoid ...

[F] Opioids for pain relief after caesarean birth

A number of women will obtain adequate analgesia with non-opioid medicines following caesarean birth, and the aim of this review is to identify the role of ...

Post-Cesarean Delivery Analgesic Outcomes in Patients ...

This 8-year, single-center, retrospective study showed that cesarean delivery patients on buprenorphine or methadone receiving similar ...

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28727661/

Comparison of Post-Cesarean Section Opioid Analgesic ...

Our study suggests that buprenorphine treatment will not interfere more than methadone with pain management after a cesarean section with no significant ...