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Clinical Trials/NCT05069311
NCT05069311CompletedNot Applicable

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

Udayana University1 site in 1 country62 target enrollmentStarted: October 15, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
62
Locations
1
Primary Endpoint
Preoperative MiRNA-124

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Hysterectomy

Experimental

Patients who undergo surgical hysterectomy that fits inclusion and exclusion criteria

Intervention: Multimodal analgesia (Drug)

Hysterectomy

Experimental

Patients who undergo surgical hysterectomy that fits inclusion and exclusion criteria

Intervention: Conventional intravenous analgesia (Drug)

Outcomes

Primary Outcomes

Preoperative MiRNA-124

Time Frame: 1-hour before surgery

serum level of MiRNA-124

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Udayana University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christopher Ryalino, MD

Principal Investigator

Udayana University

Study Sites (1)

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