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NCT Number: NCT07102641

Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies

Cesarean delivery is a commonly performed surgical procedure associated with worse postpartum pain when compared to vaginal birth. Uncontrolled postpartum pain is associated with increased neonatal and maternal risks. Multimodal non-opioid pain medications, including acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) are the preferred first-line therapies. There is no standard practice, however, on best dosing schedules (ie staggered or different time v. simultaneous or same time). This protocol describes a randomized clinical trial aimed to determine whether staggered dosing of acetaminophen and NSAIDs in superior to simultaneous dosing in controlling post-cesarean pain.

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

Cesarean delivery is a commonly performed surgical procedure. The rate of cesarean delivery (CD) is increasing in the US; cesarean accounted for 32% of all births in 2022. Parents who deliver via CD experience more pain than those who have a vaginal birth. Uncontrolled postpartum pain can be associated with an increased risk of physical complications including venous thrombosis, atelectasis, pneumonia as well as increased psychological distress. Poor postpartum pain control can also hinder infant-parental bonding and impact breastfeeding initiation or continuation.

Multiple strategies for post-operative pain management exist including opioid and non-opioid medications. Multimodal non-opioid medications are preferred as first-line therapies due to the short- and long-term risks associated with opioid pain medication. Acetaminophen and ibuprofen are most commonly utilized in the US. 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 and found a significant reduction in pain intensity for combination therapy compared to each drug alone.

Both acetaminophen and ibuprofen can be given every 6 hours. Practices differ, however, on administering these medications at the same time or in a staggered fashion. To date, there are no trials comparing these different dosing schedules for post-cesarean delivery pain control.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >/= 34 weeks gestation
  • Singleton pregnancy
  • Delivery via cesarean section under regional anesthesia

Exclusion criteria

  • Contraindication to acetaminophen or NSAIDs
  • Current or history of opioid use or misuse
  • Intrauterine fetal demise
  • Major congenital anomaly
  • Conversion to general anesthesia intra-op or planned general anesthesia
  • Mid-line vertical skin incision
  • Receipt of intraoperative local analgesia such as Transversus Abdominis Plan (TAP) block or wound infiltration

Treatment and study plan

Acetaminophen

Drug

Acetaminophen 1000 mg q6H

NSAID (Ketorolac/Ibuprofen)

Drug

NSAID (ketorolac 30 mg q6H for first 24 hours post-op followed by ibuprofen 600 mg q6H)

Primary outcomes

  1. Postpartum pain control

    Time frame: 48 (+/- 2) hours postpartum

    Visual analog pain score (VAS) with movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

  2. Opioid consumption

    Time frame: Postpartum Admission (From time of surgery to hospital discharge; typically 2-5 days)

    Opioid consumption (in total morphine milligram equivalents (MME))

Secondary outcomes

  1. Postpartum pain at 6 hours

    Time frame: 6 hours (+/- 1 hour) post-op

    Visual analog pain score with rest. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

  2. Postpartum pain at 12 hours

    Time frame: 12 hours (+/-2 hours) post-op

    Visual analog pain score with rest and movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

  3. Postpartum pain at 24 hours

    Time frame: 24 hours (+/-2 hours) post-op

    Visual analog pain score with rest and movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

  4. Postpartum pain at 48 hours

    Time frame: 48 hours (+/- 2 hours) post-op.

    Visual analog pain score with rest. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

  5. Adequate pain control

    Time frame: by 48 hours (+/-2 hours) post-op

    Adequate pain control (Visual analog score <4). Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain

  6. Length of stay

    Time frame: Admission to discharge (Typically 2-7 days)

    Duration of hospitalization

  7. Infant feeding

    Time frame: At time of hospital discharge (Typically 1- 5 days post-op)

    Exclusive breastfeeding, combination feeding, or formula feeding

  8. Patient satisfaction

    Time frame: Post-operative day #2-5.

    Patient satisfaction with pain control. Assessed via International Pain Outcomes (IPO) questionnaire. Scores for individual items in this questionnaire range from 0-10, with 0 indicating no symptoms and 10 indicating worst possible symptoms, OR from 0-100% for questions inquiring about time (0% being no time and 100% being all the time).

  9. Opioid Prescription

    Time frame: At hospital discharge (Post-operative day #2-5)

    Need for opioid prescription (Yes or No) and amount (MME)

  10. Home opioid

    Time frame: Post-operative day #10-14

    Home opioid use in the first week postpartum (Assessed by telephone call)

Study contacts

Contact information is provided by the study sponsor or research team.

Brandy Firman

CONTACT

[email protected]

215-586-1656

Whitney Bender, MD

CONTACT

[email protected]

434-294-8416

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

PACESS: Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies

Acronym: PACESS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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