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

Thomas Jefferson University

Status and phase: Enrolling; Phase 4

Conditions: Post-operative Pain; Cesarean Delivery; NSAIDs; Postpartum Comfort; Postpartum Pain; Acetaminophen (D000082)

Treatments: Drug: NSAID (Ketorolac/Ibuprofen); Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT07102641

iRISID-2024-1669

Details and patient eligibility

About

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.

Full 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.

Enrollment: 825 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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825 participants in 2 patient groups

Staggered

Active Comparator group

Description:

Medications administered 3H apart (Staggered)

Treatment:

Drug: Acetaminophen

Drug: NSAID (Ketorolac/Ibuprofen)

Simultaneous

Active Comparator group

Description:

Medications administered at the same time. (Simultaneous)

Treatment:

Drug: Acetaminophen

Drug: NSAID (Ketorolac/Ibuprofen)