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Completed

NCT Number: NCT05069311

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

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.

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Key information

Conditions

Inflammation Acute Pain Chronic Pain Inflammatory Response Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal analgesia

Drug

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

Conventional intravenous analgesia

Drug

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

Other names: Group C

Primary outcomes

  1. Preoperative MCP-1

    Time frame: 1-hour before surgery

    serum level of MCP-1

  2. Preoperative BDNF

    Time frame: 1-hour before surgery

    serum level of BDNF

  3. Preoperative MiRNA-124

    Time frame: 1-hour before surgery

    serum level of MiRNA-124

  4. Postoperative MCP-1

    Time frame: 48-hours after surgery

    serum level of MCP-1

  5. Postoperative BDNF

    Time frame: 48-hours after surgery

    serum level of BDNF

  6. Postoperative MiRNA-124

    Time frame: 48-hours after surgery

    serum level of MiRNA-124

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2021
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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