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

Primary Purpose

Inflammation, Inflammatory Response, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Multimodal analgesia
Conventional intravenous analgesia
Sponsored by
Udayana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sanglah General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hysterectomy

Arm Description

Patients who undergo surgical hysterectomy that fits inclusion and exclusion criteria

Outcomes

Primary Outcome Measures

Preoperative MCP-1
serum level of MCP-1
Preoperative BDNF
serum level of BDNF
Preoperative MiRNA-124
serum level of MiRNA-124
Postoperative MCP-1
serum level of MCP-1
Postoperative BDNF
serum level of BDNF
Postoperative MiRNA-124
serum level of MiRNA-124

Secondary Outcome Measures

Full Information

First Posted
September 23, 2021
Last Updated
August 8, 2022
Sponsor
Udayana University
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1. Study Identification

Unique Protocol Identification Number
NCT05069311
Brief Title
Effects of Multimodal Analgesia on Serum MCP-1, BDNF, and MiRNA-124 in Hysterectomy Surgery
Official Title
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
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Udayana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Inflammatory Response, Acute Pain, Chronic Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hysterectomy
Arm Type
Experimental
Arm Description
Patients who undergo surgical hysterectomy that fits inclusion and exclusion criteria
Intervention Type
Drug
Intervention Name(s)
Multimodal analgesia
Other Intervention Name(s)
Group M
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Conventional intravenous analgesia
Other Intervention Name(s)
Group C
Intervention Description
Standard analgesia includes fentanyl 2 mcg/kg (bolus) and morphine given by PCA (patient-controlled analgesia) at 1 mg/dose
Primary Outcome Measure Information:
Title
Preoperative MCP-1
Description
serum level of MCP-1
Time Frame
1-hour before surgery
Title
Preoperative BDNF
Description
serum level of BDNF
Time Frame
1-hour before surgery
Title
Preoperative MiRNA-124
Description
serum level of MiRNA-124
Time Frame
1-hour before surgery
Title
Postoperative MCP-1
Description
serum level of MCP-1
Time Frame
48-hours after surgery
Title
Postoperative BDNF
Description
serum level of BDNF
Time Frame
48-hours after surgery
Title
Postoperative MiRNA-124
Description
serum level of MiRNA-124
Time Frame
48-hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sanglah General Hospital
City
Denpasar
State/Province
Bali
ZIP/Postal Code
80114
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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