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

NCT05069311 | Completed

• 1 other identifier: UNUD-CTR-FK240921-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Inflammatory Response; Acute Pain; Chronic Pain

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Hysterectomy

EXPERIMENTAL

Patients who undergo surgical hysterectomy that fits inclusion and exclusion criteria

Drug: Multimodal analgesia; Drug: Conventional intravenous analgesia

Interventions

Multimodal analgesia DRUG

Multimodal analgesia includes the combination of: 1. morphine given by PCA (patient-controlled analgesia) at 1 mg/dose 2. bupivacaine 0.25% and dexmedetomidine 0.5 mcg/mL (total volume of 10 mL) by epidural-catheter bolus given preoperatively 3. bupicavaine 0.125% and dexmedetomidine 0.5 mcg/mL at a 5 mL/hour rate per epidural-catheter given intraoperatively 4. bupivacaine 0.1% and dexmedetomidine 0.5 mcg/mL given by programmed intermittent epidural bolus (PIEB), set to be delivered every one-hour 5. etericoxib 90 mg per oral give two-hours before surgery and then continued until three days post-surgery 6. 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

Also known as: Group M

Hysterectomy

Conventional intravenous analgesia DRUG

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

Also known as: Group C

Hysterectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

MeSH Terms

Conditions

Inflammation; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 6, 2021
• Study Start: October 15, 2021
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

ID (1)