Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain

Study Overview
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Brief Summary
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To evaluate that perioperative regular usage of propacetamol to reduce post cesarean section uterine contraction pain and opioid consumption

Detailed Description
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The most common method of pain control after cesarean section is intravenous patient-control analgesia (IVPCA) with morphine. Multimodal analgesia could improve the quality of perioperative pain control and reduceside effects of opioids. Previous researches marked that perioperative pain after cesarean section includes somatic wound pain and visceral uterine contraction pain. According to Academy of Breastfeeding Medicine, propacetamol is a safe pain-killer for an expectant mother and almost free from breast milk after intravenous injection. This study is a prospective double-blind randomized-controlled trial to evaluate that propacetamol could reduce visceral uterine contraction pain after cesarean section. Post cesarean section women will divide into three groups: pain control with IVPCA for 2 days pain control with IVPCA and propacetamol 1g every 6 hours for 2 days pain control with IVPCA and propacetamol 2g every 6 hours for 2 days

Official Title
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Perioperative Regular Usage of Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain and Opioid Consumption

Conditions
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Uterine Pain

Intervention / Treatment
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* Drug: Propacetamol 1g
* Drug: Propacetamol 2g
* Drug: IVPCA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnancy more than 36 weeks which is expected to receive Caesarean section Post Caesarean section woman, age greater than or equal to 20 years old ASA physical status class 1 or 2 Exclusion Criteria: ASA physical status class 3 or above Less than 20 years old Past caesarean section for longitudinal wounds Undergone major abdominal surgery Chronic pain Allergic to morphine or Propacetamol Liver dysfunction Treatment with anticoagulant Emergency operation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propacetamol 1g<br>pain control with IVPCA and propacetamol 1g every 6 hours for 2 days | Drug: Propacetamol 1g<br>* pain control with IVPCA and propacetamol 1g every 6 hours for 2 days<br>* Other names: Propacetamol 1g + IVPCA;Drug: IVPCA<br>* pain control with IVPCA<br>* Other names: IVPCA alone;|
| Active Comparator: propacetamol 2g<br>pain control with IVPCA and propacetamol 2g every 6 hours for 2 days | Drug: Propacetamol 2g<br>* pain control with IVPCA and propacetamol 2g every 6 hours for 2 days<br>* Other names: Propacetamol 2g + IVPCA;Drug: IVPCA<br>* pain control with IVPCA<br>* Other names: IVPCA alone;|
| Placebo Comparator: IVPCA<br>pain control with IVPCA | Drug: IVPCA<br>* pain control with IVPCA<br>* Other names: IVPCA alone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain assessed by NRS | Change of pain assessed by Numerical Rating Scale: respondent selects a whole number (0-10 integers) that best reflects the intensity of the pain | Every 8 hours from post-anesthesia care unit to 2 days after the cesarean section | 
| Incidence of treatment-relate adverse events | the complications or side effects during intervention, such as nausea/vomiting, skin itching, GI discomfort, urinary retention, and respiratory depression | Two days after the cesarean section | 
| Opioid consumption | Comparison with the placebo group, the requirement of opoid | Two days after the cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction assessed by the NRS | Participants' satisfaction about post-operative pain management assessed by Numerical Rating Scale: respondent selects a whole number (0-10 integers , dissatisfied -> satisfied) that best reflects the satisfaction. | Two days after the cesarean section | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, uterine contraction pain, propacetamol