Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain

Mackay Memorial Hospital100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Uterine Pain

Interventions

Propacetamol 1gDRUG

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

Propacetamol 2gDRUG

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

IVPCADRUG

pain control with IVPCA

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

MacKay Memorial Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Two days after the cesarean section

Opioid consumption

Comparison with the placebo group, the requirement of opoid

Time frame: Two days after the cesarean section

Secondary Outcomes

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.

Time frame: Two days after the cesarean section

Data from ClinicalTrials.gov

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