Cesarean DeliveryPhase 4PACESSNCT07102641
Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies
A Phase 4 study testing Acetaminophen and NSAID (Ketorolac/Ibuprofen) in people with Cesarean Delivery and Postpartum Comfort, run by Thomas Jefferson University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Cesarean Delivery, Postpartum Comfort, Postpartum Pain
- What is being tested?
- Acetaminophen and NSAID (Ketorolac/Ibuprofen)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- >/= 34 weeks gestation
- Singleton pregnancy
- Delivery via cesarean section under regional anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: PACESS: 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.
Read the detailed description
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.
- Conditions
- Cesarean Delivery, Postpartum Comfort, Postpartum Pain, Post-operative Pain, NSAIDs, Acetaminophen (D000082)
- Being tested
- Acetaminophen, NSAID (Ketorolac/Ibuprofen)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Staggered | Active comparator | Medications administered 3H apart (Staggered) Receives: Drug: Acetaminophen; Drug: NSAID (Ketorolac/Ibuprofen) |
| Simultaneous | Active comparator | Medications administered at the same time. (Simultaneous) Receives: Drug: Acetaminophen; Drug: NSAID (Ketorolac/Ibuprofen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum pain control
Visual analog pain score (VAS) with movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Measured: 48 (+/- 4) hours postpartum
Opioid consumption
Opioid consumption (in total morphine milligram equivalents (MME))
Measured: Postpartum Admission (From time of surgery to hospital discharge; typically 2-5 days)
Secondary outcomes (10)
Postpartum pain at 6 hours
Visual analog pain score with rest. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Measured: 6 hours (+/- 1 hour) post-op
Postpartum pain at 12 hours
Visual analog pain score with rest and movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Measured: 12 hours (+/-2 hours) post-op
Postpartum pain at 24 hours
Visual analog pain score with rest and movement. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Measured: 24 hours (+/-2 hours) post-op
Postpartum pain at 48 hours
Visual analog pain score with rest. Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Measured: 48 hours (+/- 2 hours) post-op.
Adequate pain control
Adequate pain control (Visual analog score <4). Scale ranges from 0-10 with 0 indicating no pain and 10 indicating worst possible pain
Measured: by 48 hours (+/-2 hours) post-op
Length of stay
Duration of hospitalization
Measured: Admission to discharge (Typically 2-7 days)
Infant feeding
Exclusive breastfeeding, combination feeding, or formula feeding
Measured: At time of hospital discharge (Typically 1- 5 days post-op)
Patient satisfaction
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).
Measured: Post-operative day #2-5.
Opioid Prescription
Need for opioid prescription (Yes or No) and amount (MME)
Measured: At hospital discharge (Post-operative day #2-5)
Home opioid
Home opioid use in the first week postpartum (Assessed by telephone call)
Measured: Post-operative day #10-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2025
- Study start26 Aug 2025
- Primary completion23 Jul 2026
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Whitney Bender, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102641
- Sponsor's protocol ID
- iRISID-2024-1669
- Acronym
- PACESS
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No