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Completed

NCT Number: NCT03878082

Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain

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

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Key information

Conditions

Uterine Pain

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MacKay Memorial Hospital

Taipei, 104, Taiwan

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propacetamol 1g

Drug

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

Other names: Propacetamol 1g + IVPCA

Propacetamol 2g

Drug

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

Other names: Propacetamol 2g + IVPCA

IVPCA

Drug

pain control with IVPCA

Other names: IVPCA alone

Primary outcomes

  1. 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

  2. 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

  3. Opioid consumption

    Time frame: Two days after the cesarean section

    Comparison with the placebo group, the requirement of opoid

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2019
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.