Vaginal Postpartum Pain Management Protocol Comparison

Not Applicable

Completed

• Conditions: Pain; Post Partum Depression; Opioid Use; Breast Feeding
• Interventions: Drug: Paracetamol 1000 Mg Oral Tablet; Drug: Ibuprofen 400Mg Tab; Drug: Ibuprofen 400 mg; Drug: MIR

• Registration Number: NCT04087317
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Study Start: 2020-06-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Women following term vaginal delivery.

Exclusion Criteria

1. Under Age 18 years or older than 45 years.
2. Women with chronic pain syndrome.
3. Women with relative or absolute contraindications for paracetamol or NSAIDs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
'On-demand' group.	Paracetamol 1000 Mg Oral Tablet	Patients received oral 1-gram paracetamol and 400 milligram ibuprofen at maternal request. 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).
Fixed time interval group.	Ibuprofen 400Mg Tab	Patients received oral 1-gram paracetamol and 400 milligram ibuprofen every 6 hours, in the first 24 hours postpartum. After 24 hours postpartum and until discharge, they will receive analgesics at maternal request. 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).
Fixed time interval group.	Paracetamol 1000 Mg Oral Tablet	Patients received oral 1-gram paracetamol and 400 milligram ibuprofen every 6 hours, in the first 24 hours postpartum. After 24 hours postpartum and until discharge, they will receive analgesics at maternal request. 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).
Fixed time interval group.	MIR	Patients received oral 1-gram paracetamol and 400 milligram ibuprofen every 6 hours, in the first 24 hours postpartum. After 24 hours postpartum and until discharge, they will receive analgesics at maternal request. 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).
'On-demand' group.	Ibuprofen 400 mg	Patients received oral 1-gram paracetamol and 400 milligram ibuprofen at maternal request. 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).
'On-demand' group.	MIR	Patients received oral 1-gram paracetamol and 400 milligram ibuprofen at maternal request. 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).

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) score difference in the 24 first hours.	In the first 24 hours postpartum.	Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).

Secondary Outcome Measures

Name	Time	Method
Amount of additional analgesia requirements.	Up to maternal discharge (5 days)	Total amount of additional analgesia up to maternal discharge.
Total analgesia requirements.	Up to 48 hours postpartum.	Total amount of analgesics use during 48 hours following a vaginal delivery.
Breastfeeding rate.	Up to 48 hours postpartum.	The rate of women who breastfeed their newborns and breastfeeding frequency.
Treatments side effects.	Up to 48 hours postpartum.	Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia.
Visual analog scale (VAS) score difference up to maternal discharge.	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). up to 5 days.	Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).

Trial Locations

Locations (1)

Rambam; 🇮🇱 Ramat Yishai, Israel