Vaginal Postpartum Pain Management Protocol Comparison

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery

Conditions
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Pain, Post Partum Depression, Opioid Use, Breast Feeding

Intervention / Treatment
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* Drug: Paracetamol 500 Mg Oral Tablet
* Drug: Ibuprofen 400Mg Tab
* Drug: Paracetamol 500 Mg Oral Tablet
* Drug: Ibuprofen 400 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Women following term vaginal delivery. Exclusion Criteria: Under Age 18 years or older than 45 years. Women with chronic pain syndrome. Women with relative or absolute contraindications for paracetamol or NSAIDs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Women following a vaginal delivery, with no exclusion criteria to participate in the study, will be addressed. After receiving all the information about the study, women who choose to participate will be consented. All participants will be randomized to either scheduled analgesic administration (study group) or analgesic administration per women's request (control group) as accustomed at the investigator's unit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed time interval group.<br>Once the patient will arrive at the maternity ward the patient will receive paracetamol 1 gram and a tablet of ibuprofen 400 mg. Six hours after patient arrival and every 6 hours the patient will receive a tablet of paracetamol 500 mg and a tablet of ibuprofen 400 mg. | Drug: Paracetamol 500 Mg Oral Tablet<br>* The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.<br>* Other names: Acetaminophen;Drug: Ibuprofen 400Mg Tab<br>* The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.<br>|
| Experimental: 'On-demand' group.<br>Patients allocated to this group will receive the same medications in the same combinations and order as described in the 'fixed time interval' group protocol, patients in this group will receive pain treatment only following demand, and the time intervals described above will be considered as the minimal time for giving the next combination of drugs. | Drug: Paracetamol 500 Mg Oral Tablet<br>* The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.<br>* Other names: Acetaminophen;Drug: Ibuprofen 400 mg<br>* The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) score difference. | Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction). | Up to 48 hours postpartum. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of additional analgesia requirements. | Total amount of additional analgesia 48 hours following a vaginal delivery. | Up to 48 hours postpartum. | 
| Total analgesia requirements. | Total amount of analgesics use during 48 hours following a vaginal delivery. | Up to 48 hours postpartum. | 
| Breastfeeding rate. | The rate of women who breastfeed their newborns and breastfeeding frequency. | Up to 48 hours postpartum. | 
| Treatments side effects. | Side effects reported by the medical staff (clinically or laboratory) or women receiving analgesia. | Up to 48 hours postpartum. |