Clinical trial NCT03878082: Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain
Official title: Perioperative Regular Usage of Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain and Opioid Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Pain
Keywords: cesarean section
uterine contraction pain
propacetamol
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change of pain assessed by NRS
timeFrame: Every 8 hours from post-anesthesia care unit to 2 days after the cesarean section
measure: Incidence of treatment-relate adverse events
timeFrame: Two days after the cesarean section
measure: Opioid consumption
timeFrame: Two days after the cesarean section
Secondary outcomes:
measure: Satisfaction assessed by the NRS
timeFrame: Two days after the cesarean section
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Chien-Chung Huang, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.