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Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03878082
Enrollment
100
Registered
2019-03-18
Start date
2019-08-12
Completion date
2022-12-31
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Pain

Keywords

cesarean section, uterine contraction pain, propacetamol

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

Interventions

DRUGPropacetamol 1g

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

DRUGPropacetamol 2g

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

DRUGIVPCA

pain control with IVPCA

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of pain assessed by NRSEvery 8 hours from post-anesthesia care unit to 2 days after the cesarean sectionChange of pain assessed by Numerical Rating Scale: respondent selects a whole number (0-10 integers) that best reflects the intensity of the pain
Incidence of treatment-relate adverse eventsTwo days after the cesarean sectionthe complications or side effects during intervention, such as nausea/vomiting, skin itching, GI discomfort, urinary retention, and respiratory depression
Opioid consumptionTwo days after the cesarean sectionComparison with the placebo group, the requirement of opoid

Secondary

MeasureTime frameDescription
Satisfaction assessed by the NRSTwo days after the cesarean sectionParticipants' 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026