Effects of Multimodal Analgesia on Serum MCP-1, BDNF, and MiRNA-124 in Hysterectomy Surgery

Overview

The inflammatory process is the main mechanism in the occurrence of acute postoperative pain. It is also the main risk for the development of acute pain into persistent pain. Inflammation occurs in the process of peripheral sensitization and central sensitization with various inflammatory mediators. Postoperatively, there will be proliferation and activation of microglia and astrocytes which will then activate inflammatory receptors and signaling cascades of neurotransmitters, cytokines, and chemokines. There has been a lot of clinical research evidence that multimodal analgesia can adequately treat acute pain and can prevent the development of acute postoperative pain into persistent pain and chronic postoperative pain, but the molecular mechanisms are not fully understood.

Full Title of Study: “Effects of Multimodal Analgesia on Monocyte Chemoattractant Protein-1, Brain-derived Neurotrophic Factor, and RNA-124 Micro to Acute Pain in Patients Who Underwent Hysterectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 30, 2022

Interventions

  • Drug: Multimodal analgesia
    • Multimodal analgesia includes the combination of: morphine given by PCA (patient-controlled analgesia) at 1 mg/dose bupivacaine 0.25% and dexmedetomidine 0.5 mcg/mL (total volume of 10 mL) by epidural-catheter bolus given preoperatively bupicavaine 0.125% and dexmedetomidine 0.5 mcg/mL at a 5 mL/hour rate per epidural-catheter given intraoperatively bupivacaine 0.1% and dexmedetomidine 0.5 mcg/mL given by programmed intermittent epidural bolus (PIEB), set to be delivered every one-hour etericoxib 90 mg per oral give two-hours before surgery and then continued until three days post-surgery paracetamol 1 g (intravenously) given on the day of the surgery, continued at 10 mg/kg dose every 8 hours until three days post-surgery
  • Drug: Conventional intravenous analgesia
    • Standard analgesia includes fentanyl 2 mcg/kg (bolus) and morphine given by PCA (patient-controlled analgesia) at 1 mg/dose

Arms, Groups and Cohorts

  • Experimental: Hysterectomy
    • Patients who undergo surgical hysterectomy that fits inclusion and exclusion criteria

Clinical Trial Outcome Measures

Primary Measures

  • Preoperative MCP-1
    • Time Frame: 1-hour before surgery
    • serum level of MCP-1
  • Preoperative BDNF
    • Time Frame: 1-hour before surgery
    • serum level of BDNF
  • Preoperative MiRNA-124
    • Time Frame: 1-hour before surgery
    • serum level of MiRNA-124
  • Postoperative MCP-1
    • Time Frame: 48-hours after surgery
    • serum level of MCP-1
  • Postoperative BDNF
    • Time Frame: 48-hours after surgery
    • serum level of BDNF
  • Postoperative MiRNA-124
    • Time Frame: 48-hours after surgery
    • serum level of MiRNA-124

Participating in This Clinical Trial

Inclusion Criteria

  • Scheduled for elective hysterectomy – American Society of Anesthesiologists (ASA) physical status 1 to 3 Exclusion Criteria:

  • allergy to studied drugs – history of chronic pain – history of hepatitis, depression, peptic ulcer, or acute myocardial infarction – receive intraoperative massive blood transfusion – prolonged coagulation – body mass index >35 kg/m2 – patients with neurological deficits – taking anti-platelet medications

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Udayana University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christopher Ryalino, MD, Principal Investigator – Udayana University

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