Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain

Overview

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

Full Title of Study: “Perioperative Regular Usage of Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain and Opioid Consumption”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2020

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

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: propacetamol 1g
    • pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
  • Active Comparator: propacetamol 2g
    • pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
  • Placebo Comparator: IVPCA
    • pain control with IVPCA

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • Opioid consumption
    • Time Frame: Two days after the cesarean section
    • Comparison with the placebo group, the requirement of opoid

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Post Caesarean section woman

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mackay Memorial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chien-Chung,Huang, attending physician, department of anesthesiology – Mackay Memorial Hospital
  • Overall Official(s)
    • Chien-Chung Huang, MD, Study Director, Mackay Memorial Hospital

References

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.

Ortiz MI, Ponce-Monter HA, Mora-Rodríguez JA, Barragán-Ramírez G, Barrón-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.

Gadsden J, Hart S, Santos AC. Post-cesarean delivery analgesia. Anesth Analg. 2005 Nov;101(5 Suppl):S62-9. Review.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.