NCT04087317

Vaginal Postpartum Pain Management Protocol Comparison

Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.

Detailed description

More than two million women deliver vaginally every year in the United States (US). Along with the joy and happiness of having a new member in the family, women may suffer from cramping pain and lower abdomen discomfort following uterine involution; perineal pain due to perineal trauma or episiotomy; and nipple pain from breastfeeding or breast engorgement. A stepwise approach using multimodal combination of medications can effectively provide an individualized pain management for women in their postpartum period. The first step includes non-opioid analgesics (as paracetamol and NSAIDs), step two adds milder opioids (as codeine, tramadol and oral morphine), and step three incorporates stronger opioids (as parenteral morphine). In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.

Conditions

• Pain
• Post Partum Depression
• Opioid Use
• Breast Feeding

Interventions

Type	Name	Description
DRUG	Paracetamol 1000 Mg Oral Tablet	The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
DRUG	Ibuprofen 400Mg Tab	The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
DRUG	Paracetamol 1000 Mg Oral Tablet	The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
DRUG	Ibuprofen 400 mg	The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
DRUG	MIR	At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-06-30
• Completion: 2022-07-30
• First posted: 2019-09-12
• Last updated: 2024-01-03

Locations

1 site across 1 country: Israel