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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069311
• Other study ID #: UNUD-CTR-FK240921-001
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Udayana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Inflammation
• Inflammatory Response

Intervention

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
• Conventional intravenous analgesia
Standard analgesia includes fentanyl 2 mcg/kg (bolus) and morphine given by PCA (patient-controlled analgesia) at 1 mg/dose

Locations

Country	Name	City	State
Indonesia	Sanglah General Hospital	Denpasar	Bali

Sponsors (1)

Lead Sponsor	Collaborator
Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative MCP-1	serum level of MCP-1	1-hour before surgery
Primary	Preoperative BDNF	serum level of BDNF	1-hour before surgery
Primary	Preoperative MiRNA-124	serum level of MiRNA-124	1-hour before surgery
Primary	Postoperative MCP-1	serum level of MCP-1	48-hours after surgery
Primary	Postoperative BDNF	serum level of BDNF	48-hours after surgery
Primary	Postoperative MiRNA-124	serum level of MiRNA-124	48-hours after surgery