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

NCT ID: NCT05069311

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-15
• Study Completion Date: 2022-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hysterectomy

Patients who undergo surgical hysterectomy that fits inclusion and exclusion criteria

Group Type: EXPERIMENTAL

Multimodal analgesia

Intervention Type: 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

Conventional intravenous analgesia

Intervention Type: DRUG

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

Interventions

Multimodal analgesia

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

Intervention Type: DRUG

Conventional intravenous analgesia

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

Intervention Type: DRUG

Other Intervention Names

Group M; Group C

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Udayana University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Ryalino, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sanglah General Hospital

Denpasar, Bali, Indonesia

Countries

Indonesia

Other Identifiers

UNUD-CTR-FK240921-001

Identifier Type: -

Identifier Source: org_study_id