Vaginal Postpartum Pain Management Protocol Comparison

Pain Clinical Trial

Official title:

Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087317
• Other study ID #: Rambam Health Care Center.
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2023
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• Paracetamol 1000 Mg Oral Tablet
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
• Ibuprofen 400 mg
The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
• 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).

Locations

Country	Name	City	State
Israel	Rambam	Ramat Yishai

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS) score difference in the 24 first hours.	Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).	In the first 24 hours postpartum.
Secondary	Amount of additional analgesia requirements.	Total amount of additional analgesia up to maternal discharge.	Up to maternal discharge (5 days)
Secondary	Total analgesia requirements.	Total amount of analgesics use during 48 hours following a vaginal delivery.	Up to 48 hours postpartum.
Secondary	Breastfeeding rate.	The rate of women who breastfeed their newborns and breastfeeding frequency.	Up to 48 hours postpartum.
Secondary	Treatments side effects.	Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia.	Up to 48 hours postpartum.
Secondary	Visual analog scale (VAS) score difference up to maternal discharge.	Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).	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.