Acetaminophen + NSAIDs for C-Section Pain

(PACESS Trial)

Overseen By Whitney Bender, MD

Age: Any Age

Sex: Female

Trial Phase: Phase 4

Sponsor: Thomas Jefferson University

Must not be taking: Opioids

Disqualifiers: Opioid use, Fetal demise, 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: Unknown

Duration: 48 hours

825 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two schedules for administering pain medicines, acetaminophen and NSAIDs (nonsteroidal anti-inflammatory drugs, such as Ketorolac or Ibuprofen), to mothers after a C-section. The researchers aim to determine if taking these medications at different times (staggered) is more effective than taking them together (simultaneous) for managing post-surgery pain. Women pregnant with one baby, at least 34 weeks along, and undergoing a C-section with regional anesthesia are ideal candidates for this study. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how they can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently using opioids, you would not be eligible to participate.

What is the safety track record for acetaminophen and NSAIDs?

Research has shown that acetaminophen and NSAIDs, such as ibuprofen or ketorolac, are safe and effective for managing pain after a C-section. A review of 21 studies involving 1,909 patients found that using these drugs together is more effective than using each one alone. This combination can reduce the need for stronger painkillers.

Studies also found that ketorolac can reduce opioid use by 25-45%, which is beneficial because opioids often have more side effects. Additionally, ibuprofen has proven more effective than ketorolac for easing pain after a C-section.

Both acetaminophen and NSAIDs are well-tolerated and commonly used for pain relief. They are often part of a step-by-step approach to managing pain after childbirth. While every medication can have side effects, these are generally mild and manageable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial for C-section pain management because it explores the timing of medication administration, which could enhance pain relief. Most current treatments involve taking acetaminophen and NSAIDs together. However, this trial compares two strategies: taking the medications simultaneously versus staggering their administration three hours apart. By investigating these methods, researchers aim to determine if one approach offers better pain control, potentially leading to improved recovery experiences for new mothers.

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

Research has shown that combining acetaminophen with NSAIDs like ibuprofen and ketorolac manages pain after a C-section more effectively than using each drug alone. This trial will compare two administration methods: the "Staggered" arm, where medications are given 3 hours apart, and the "Simultaneous" arm, where medications are given at the same time. One study found that these drugs work better together for pain control. Another study found that intravenous (IV) ibuprofen reduces pain more effectively than IV ketorolac. These medications are preferred for pain relief after childbirth because they are non-opioid options. They work well by addressing pain in different ways, resulting in a stronger combined effect. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone a cesarean delivery and are experiencing postoperative pain. It's designed to help those seeking non-opioid pain relief options, specifically using acetaminophen and NSAIDs. The study excludes participants with specific criteria not provided here.

Inclusion Criteria

34 weeks gestation or more

I had a C-section with regional anesthesia.

Singleton pregnancy

Exclusion Criteria

I have received local pain relief during surgery.

Current or history of opioid use or misuse

I cannot take acetaminophen or NSAIDs due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either staggered or simultaneous dosing of acetaminophen and NSAIDs for post-cesarean pain control

48 hours

In-hospital monitoring

Follow-up

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

2-5 days

In-hospital monitoring

Home Follow-up

Participants' home opioid use is assessed via telephone call

10-14 days post-op

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen
• NSAID (Ketorolac/Ibuprofen)

Trial Overview

The study tests the effectiveness of staggered versus simultaneous dosing schedules of two common pain relievers—acetaminophen and NSAIDs—after cesarean delivery. Participants will be randomly assigned to receive either staggered or simultaneous doses to manage their postoperative pain.

How Is the Trial Designed?

Group I: Staggered Active Control 2 Interventions

Medications administered 3H apart (Staggered)

Group II: Simultaneous Active Control 2 Interventions

Medications administered at the same time. (Simultaneous)

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8923051/

Oral analgesia for relieving post‐caesarean pain - PMC

There was no difference in need for additional pain relief with the use of celexocib, ibuprofen, ketoprofen, naproxen, paracetamol. Maternal drug effects were ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2589933319300187

Comparison of 3 protocols for analgesia control after ...

Conclusion. Administration of pain relief analgesia (ibuprofen and acetaminophen) in fixed time intervals (intravenous or oral) after cesarean delivery yielded ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07102641

Study Details | NCT07102641 | Post-cesarean Analgesia ...

A meta-analysis of 21 studies enrolling 1909 post-operative patients examined the efficacy of NSAIDs and parecetamol in combination compared to each drug alone ...

4.

journals.lww.com

journals.lww.com/raic/fulltext/2024/11010/the_effectiveness_of_intravenous_ibuprofen_versus.4.aspx

The effectiveness of intravenous ibuprofen versus...

Conclusions. Intravenous ibuprofen is more effective than intravenous ketorolac in reducing postoperative pain following caesarean delivery. It reduces the 24-h ...

5.

acog.org

acog.org/clinical/clinical-guidance/clinical-consensus/articles/2021/09/pharmacologic-stepwise-multimodal-approach-for-postpartum-pain-management

Pharmacologic Stepwise Multimodal Approach for ...

For postoperative cesarean pain, a stepwise multimodal approach should include standard oral and parenteral analgesic adjuvants such as acetaminophen, NSAIDs, ...

6.

bmcanesthesiol.biomedcentral.com

bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-020-01147-y

Efficacy of non-opioid analgesics to control postoperative pain

Studies have found that ketorolac reduces opioid consumption by 25–45% and provides additional benefits such as improving bowel function after ...