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Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain

Sponsor
Mackay Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03878082
Collaborator
(none)
100
Enrollment
1
Location
3
Arms
40.6
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Propacetamol 1g
  • Drug: Propacetamol 2g
  • Drug: IVPCA
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Perioperative Regular Usage of Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain and Opioid Consumption
Actual Study Start Date :
Aug 12, 2019
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: propacetamol 1g

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

Drug: Propacetamol 1g
pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
Other Names:
  • Propacetamol 1g + IVPCA

    • Drug: IVPCA
    pain control with IVPCA
    Other Names:
  • IVPCA alone

    		•
    Active Comparator: propacetamol 2g

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

    Drug: Propacetamol 2g
    pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
    Other Names:
  • Propacetamol 2g + IVPCA

    • Drug: IVPCA
    pain control with IVPCA
    Other Names:
  • IVPCA alone

    		•
    Placebo Comparator: IVPCA

    pain control with IVPCA

    Drug: IVPCA
    pain control with IVPCA
    Other Names:
  • IVPCA alone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. Opioid consumption [Two days after the cesarean section]

      Comparison with the placebo group, the requirement of opoid

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MacKay Memorial Hospital Taipei Taiwan 104

    Sponsors and Collaborators

    • Mackay Memorial Hospital

    Investigators

    • Study Director: Chien-Chung Huang, MD, Mackay Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chien-Chung,Huang, attending physician, department of anesthesiology, Mackay Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT03878082
    Other Study ID Numbers:
    • 19MMHIS044e
    First Posted:
    Mar 18, 2019
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chien-Chung,Huang, attending physician, department of anesthesiology, Mackay Memorial Hospital
    cesarean section
    uterine contraction pain
    propacetamol
    Additional relevant MeSH terms:
    Acetaminophen
    Propacetamol

    Study Results

    No Results Posted as of Aug 31, 2021