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

Sponsor

Udayana University (Other)

Overall Status

Completed

CT.gov ID

NCT05069311

Collaborator

(none)

Enrollment

Location

Arm

8.5

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation Inflammatory Response Acute Pain Chronic Pain	Drug: Multimodal analgesia Drug: Conventional intravenous analgesia	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 15, 2021

Actual Primary Completion Date :

Mar 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hysterectomy Patients who undergo surgical hysterectomy that fits inclusion and exclusion criteria	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 Other Names: Group M Drug: Conventional intravenous analgesia Standard analgesia includes fentanyl 2 mcg/kg (bolus) and morphine given by PCA (patient-controlled analgesia) at 1 mg/dose Other Names: Group C

Arm

Intervention/Treatment

Experimental: Hysterectomy

Patients who undergo surgical hysterectomy that fits inclusion and exclusion criteria

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

Other Names:

Group M

Drug: Conventional intravenous analgesia

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

Other Names:

Group C

Outcome Measures

Primary Outcome Measures

Preoperative MCP-1 [1-hour before surgery]
serum level of MCP-1
Preoperative BDNF [1-hour before surgery]
serum level of BDNF
Preoperative MiRNA-124 [1-hour before surgery]
serum level of MiRNA-124
Postoperative MCP-1 [48-hours after surgery]
serum level of MCP-1
Postoperative BDNF [48-hours after surgery]
serum level of BDNF
Postoperative MiRNA-124 [48-hours after surgery]
serum level of MiRNA-124

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanglah General Hospital	Denpasar	Bali	Indonesia	80114

Sponsors and Collaborators

Udayana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christopher Ryalino, MD, Principal Investigator, Udayana University

ClinicalTrials.gov Identifier:

NCT05069311

Other Study ID Numbers:

UNUD-CTR-FK240921-001

First Posted:

Oct 6, 2021

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammation

Chronic Pain

Acute Pain

Study Results

No Results Posted as of Aug 10, 2022