Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetaminophen, NSAID (Ketorolac/Ibuprofen).
- Who it may be relevant to
- Registry conditions: Cesarean Delivery, Postpartum Comfort, Postpartum Pain, Post-operative Pain. Basic parameters: from 16 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PACESS: Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies
Overview
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.
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.
Interventions
- Drug Acetaminophen
Acetaminophen 1000 mg q6H - Drug NSAID (Ketorolac/Ibuprofen)
NSAID (ketorolac 30 mg q6H for first 24 hours post-op followed by ibuprofen 600 mg q6H)
Primary outcome measures
- Postpartum pain control [Time frame: 48 (+/- 2) hours postpartum]
- Opioid consumption [Time frame: Postpartum Admission (From time of surgery to hospital discharge; typically 2-5 days)]
Secondary outcome measures (10)
- Postpartum pain at 6 hours [Time frame: 6 hours (+/- 1 hour) post-op]
- Postpartum pain at 12 hours [Time frame: 12 hours (+/-2 hours) post-op]
- Postpartum pain at 24 hours [Time frame: 24 hours (+/-2 hours) post-op]
- Postpartum pain at 48 hours [Time frame: 48 hours (+/- 2 hours) post-op.]
- Adequate pain control [Time frame: by 48 hours (+/-2 hours) post-op]
- Length of stay [Time frame: Admission to discharge (Typically 2-7 days)]
- Infant feeding [Time frame: At time of hospital discharge (Typically 1- 5 days post-op)]
- Patient satisfaction [Time frame: Post-operative day #2-5.]
- Opioid Prescription [Time frame: At hospital discharge (Post-operative day #2-5)]
- Home opioid [Time frame: Post-operative day #10-14]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Thomas Jefferson University Hospital — Philadelphia
Identifiers
NCT: NCT07102641 · iRISID-2024-1669