Acetaminophen (D000082), Cesarean Delivery, NSAIDs, Post-operative Pain, Postpartum Comfort, Postpartum Pain
Conditions
Brief 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. 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
DRUGAcetaminophen
Acetaminophen 1000 mg q6H
DRUGNSAID (Ketorolac/Ibuprofen)
NSAID (ketorolac 30 mg q6H for first 24 hours post-op followed by ibuprofen 600 mg q6H)
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum pain control | 48 (+/- 4) 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 |
| Opioid consumption | Postpartum Admission (From time of surgery to hospital discharge; typically 2-5 days) | Opioid consumption (in total morphine milligram equivalents (MME)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum pain at 6 hours | 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 |
| Postpartum pain at 12 hours | 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 |
| Postpartum pain at 24 hours | 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 |
| Postpartum pain at 48 hours | 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 |
| Adequate pain control | 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 |
| Length of stay | Admission to discharge (Typically 2-7 days) | Duration of hospitalization |
| Infant feeding | At time of hospital discharge (Typically 1- 5 days post-op) | Exclusive breastfeeding, combination feeding, or formula feeding |
| Patient satisfaction | 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). |
| Opioid Prescription | At hospital discharge (Post-operative day #2-5) | Need for opioid prescription (Yes or No) and amount (MME) |
| Home opioid | Post-operative day #10-14 | Home opioid use in the first week postpartum (Assessed by telephone call) |
Countries
United States
Outcome results
None listed