Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain

Not Applicable

Completed

• Conditions: Uterine Pain
• Interventions: Drug: Propacetamol 2g; Drug: IVPCA; Drug: Propacetamol 1g

• Registration Number: NCT03878082
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

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

Detailed Description

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:

1. pain control with IVPCA for 2 days

2. pain control with IVPCA and propacetamol 1g every 6 hours for 2 days

3. pain control with IVPCA and propacetamol 2g every 6 hours for 2 days

Study Timeline

• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-18
• Study Start: 2019-08-12
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propacetamol 2g	Propacetamol 2g	pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
IVPCA	IVPCA	pain control with IVPCA
propacetamol 1g	Propacetamol 1g	pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
propacetamol 1g	IVPCA	pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
propacetamol 2g	IVPCA	pain control with IVPCA and propacetamol 2g every 6 hours for 2 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Satisfaction assessed by the NRS	Two days after the cesarean section	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.

Trial Locations

Locations (1)

MacKay Memorial Hospital; 🇨🇳 Taipei, Taiwan