Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain

March 13, 2023 updated by: Chien-Chung,Huang, Mackay Memorial Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: IVPCA
pain control with IVPCA
Other Names:
  • IVPCA alone
Drug: Propacetamol 2g
pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
Other Names:
  • Propacetamol 2g + IVPCA
Placebo Comparator: IVPCA
pain control with IVPCA
Drug: IVPCA
pain control with IVPCA
Other Names:
  • IVPCA alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of pain assessed by NRS
Time Frame: 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
Every 8 hours from post-anesthesia care unit to 2 days after the cesarean section
Incidence of treatment-relate adverse events
Time Frame: 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
Two days after the cesarean section
Opioid consumption
Time Frame: Two days after the cesarean section
Comparison with the placebo group, the requirement of opoid
Two days after the cesarean section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction assessed by the NRS
Time Frame: 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.
Two days after the cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2019

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19MMHIS044e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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