Vaginal Postpartum Pain Management Protocol Comparison

Rambam Health Care Campus

Status: Completed

Conditions: Breast Feeding; Opioid Use; Pain; Post Partum Depression

Treatments: Drug: MIR; Drug: Paracetamol 1000 Mg Oral Tablet; Drug: Ibuprofen 400Mg Tab; Drug: Ibuprofen 400 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04087317

Rambam Health Care Center.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Fixed time interval group.

Experimental group

Description:

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).

Treatment:

Drug: MIR

Drug: Paracetamol 1000 Mg Oral Tablet

Drug: Ibuprofen 400Mg Tab

Drug: Paracetamol 1000 Mg Oral Tablet

'On-demand' group.

Experimental group

Description:

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).

Treatment:

Drug: MIR

Drug: Paracetamol 1000 Mg Oral Tablet

Drug: Ibuprofen 400 mg

Drug: Paracetamol 1000 Mg Oral Tablet