NCT03878082

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

August 12, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

3.4 years

First QC Date

March 7, 2019

Last Update Submit

March 13, 2023

Conditions

Uterine Pain

Keywords

cesarean sectionuterine contraction painpropacetamol

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    Two days after the cesarean section

  • Opioid consumption

    Comparison with the placebo group, the requirement of opoid

    Two days after the cesarean section

Secondary Outcomes (1)

  • Satisfaction assessed by the NRS

    Two days after the cesarean section

Study Arms (3)

propacetamol 1g

ACTIVE COMPARATOR

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

Drug: Propacetamol 1gDrug: IVPCA

propacetamol 2g

ACTIVE COMPARATOR

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

Drug: Propacetamol 2gDrug: IVPCA

IVPCA

PLACEBO COMPARATOR

pain control with IVPCA

Drug: IVPCA

Interventions

Propacetamol 1gDRUG

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

Also known as: Propacetamol 1g + IVPCA
propacetamol 1g
Propacetamol 2gDRUG

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

Also known as: Propacetamol 2g + IVPCA
propacetamol 2g
IVPCADRUG

pain control with IVPCA

Also known as: IVPCA alone
IVPCApropacetamol 1gpropacetamol 2g

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPost Caesarean section woman
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MacKay Memorial Hospital

Taipei, 104, Taiwan

Location

Related Publications (3)

  • Valentine AR, Carvalho B, Lazo TA, Riley ET. Scheduled acetaminophen with as-needed opioids compared to as-needed acetaminophen plus opioids for post-cesarean pain management. Int J Obstet Anesth. 2015 Aug;24(3):210-6. doi: 10.1016/j.ijoa.2015.03.006. Epub 2015 Mar 23.

    PMID: 25936786BACKGROUND

  • Ortiz MI, Ponce-Monter HA, Mora-Rodriguez JA, Barragan-Ramirez G, Barron-Guerrero BS. Synergistic relaxing effect of the paracetamol and pyrilamine combination in isolated human myometrium. Eur J Obstet Gynecol Reprod Biol. 2011 Jul;157(1):22-6. doi: 10.1016/j.ejogrb.2011.02.011. Epub 2011 Mar 24.

    PMID: 21439705BACKGROUND

  • Gadsden J, Hart S, Santos AC. Post-cesarean delivery analgesia. Anesth Analg. 2005 Nov;101(5 Suppl):S62-S69. doi: 10.1213/01.ANE.0000177100.08599.C8.

    PMID: 16334493BACKGROUND

MeSH Terms

Interventions

propacetamol

Study Officials

  • Chien-Chung Huang, MD

    Mackay Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician, department of anesthesiology

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 18, 2019

Study Start

August 12, 2019

Primary Completion

December 30, 2022

Study Completion

December 31, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)