Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period

Study Overview
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Brief Summary
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The investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period

Detailed Description
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Postpartum pain is a common problem that leads to difficulties in basic daily activities, overuse of opioid medications, and even impaired breastfeeding ability. Non-opioid analgesia may play an essential role in reducing pain and improving the postpartum period including the ability to breastfeed and caring for the newborn. This study will compare non-opioid treatment - 1000 mg Paracetamol versus 400 mg Ibuprofen in order to determine the optimal pain relief treatment in the early postpartum period that may decrease the use of opioid analgesia. The investigators will evaluate the pain by the Numerical Rating Scale (NRS) index in the early postpartum period. The evaluation will conduct at 4-time points - while the women taking the pain relief (time 0), an hour later (time 1), 4, and 6 hours later (time 4 and time 6). The investigators will compare the analgetic effect of each drug and evaluate the need for additional analgesia whether opioid or not. Furthermore, the investigators will examine when women sought pain relief and whether pain relief contributes to the ability of Breastfeeding.

Official Title
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Non - Opioid Treatments (Single Administration) for Pain During the Early Postpartum Period After Vaginal Delivery

Conditions
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Pain

Intervention / Treatment
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* Drug: Paracetamol 1000 mg
* Drug: Ibuprofen 400 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between the ages of 18-50, who gave birth in a vaginal birth Exclusion Criteria: Sensitivity to Paracetamol or Ibuprofen After cesarean section Received analgesia prior to study recruitment Perineal tears grade 3 \ 4 Women with chronic pain, rheumatic disease, fibromyalgia, or trauma Women with a diagnosis or medication for anxiety or depression Dropout for women whose newborns needed respiratory support with intubation, cooling, prolonged hospitalization in NICU exceeding one week

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia (NRS <3) Pain Reliefs will be given in a double-blind mechanism, in closed envelopes The envelopes will contain Paracetamol 1000 mg or Ibuprofen 400 mg Women participating in the study will answer a questionnaire to characterize the pain while taking the pain relief (time 0), an hour later (time 1), 4 and 6 hours later (time 4 and time 6)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracetamol group<br>Women who were treated with a double-blind mechanism in an envelope containing paracetamol pills (1000 mg) | Drug: Paracetamol 1000 mg<br>* Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg<br>|
| Experimental: Ibuprofen group<br>Women who were treated with a double-blind mechanism in an envelope containing Ibuprofen pills (400 mg) | Drug: Ibuprofen 400 mg<br>* Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief after treatment with Paracetamol or Ibuprofen | After getting a pain relief treatment, the participants will answer a questionnaire about pain relief at 4 - time points: the time of getting the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6). The pain rating will be on the Numeric Rating Scale (NRS) that labeled from zero (no pain) to ten ((worst pain). | 6 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum pain location | After getting a pain relief treatment, the participants will answer a questionnaire about pain relief at 4 - time points: the time of getting the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6). The questionnaire will describe the maximal pain location area and the effectiveness of analgesic treatment in this area (by rating the pain on the NRS). The questionnaire will be at the time of taking the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6) | 6 hours after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Partum Pain, Pain Relief, Non-Opioids Analgesia