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Clinical trial

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

ID
Name
19MMHIS044e
Description
To evaluate that perioperative regular usage of propacetamol to reduce post cesarean section uterine contraction pain and opioid consumption
Trial arms
Trial start
2019-08-12
Estimated PCD
2022-12-30
Trial end
2022-12-31
Status
Completed
Treatment
Propacetamol 1g
pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
Arms:
propacetamol 1g
Other names:
Propacetamol 1g + IVPCA
Propacetamol 2g
pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
Arms:
propacetamol 2g
Other names:
Propacetamol 2g + IVPCA
IVPCA
pain control with IVPCA
Arms:
IVPCA, propacetamol 1g, propacetamol 2g
Other names:
IVPCA alone
Size
100
Primary endpoint
Change of pain assessed by NRS
Every 8 hours from post-anesthesia care unit to 2 days after the cesarean section
Incidence of treatment-relate adverse events
Two days after the cesarean section
Opioid consumption
Two days after the cesarean section
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2023-03-15

1 organization

2 products

1 indication

Organization
Mackay Memorial Hospital
Product
Propacetamol
Indication
Uterine Pain
Product
IVPCA