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

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Chronic Pain; Inflammatory Response; Acute Pain
• Intervention / Treatment: Drug: Multimodal analgesia; Drug: Conventional intravenous analgesia

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80114
      • Sanglah General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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; Other Names: Group M; Drug: Conventional intravenous analgesia; Standard analgesia includes fentanyl 2 mcg/kg (bolus) and morphine given by PCA (patient-controlled analgesia) at 1 mg/dose; Other Names: Group C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative MCP-1	serum level of MCP-1	1-hour before surgery
Preoperative BDNF	serum level of BDNF	1-hour before surgery
Preoperative MiRNA-124	serum level of MiRNA-124	1-hour before surgery
Postoperative MCP-1	serum level of MCP-1	48-hours after surgery
Postoperative BDNF	serum level of BDNF	48-hours after surgery
Postoperative MiRNA-124	serum level of MiRNA-124	48-hours after surgery

Collaborators and Investigators

• Sponsor: Udayana University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Inflammation; Chronic Pain; Acute Pain
• Other Study ID Numbers: UNUD-CTR-FK240921-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No