InflammationNCT05069311
Effects of Multimodal Analgesia on Serum MCP-1, BDNF, and MiRNA-124 in Hysterectomy Surgery
A study testing Multimodal analgesia and Conventional intravenous analgesia in people with Inflammation and Inflammatory Response, run by Udayana University at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Inflammation, Inflammatory Response, Acute Pain
- What is being tested?
- Multimodal analgesia and Conventional intravenous analgesia
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Oct 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective hysterectomy
- American Society of Anesthesiologists (ASA) physical status 1 to 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Multimodal analgesia, Conventional intravenous analgesia
- Medical subject headings
- Inflammation, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal analgesiaDrug
Also called Group M
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 analgesiaDrug
Also called Group C
Standard analgesia includes fentanyl 2 mcg/kg (bolus) and morphine given by PCA (patient-controlled analgesia) at 1 mg/dose
| Study group | Role | What they receive |
|---|---|---|
| Hysterectomy | Experimental | Patients who undergo surgical hysterectomy that fits inclusion and exclusion criteria Receives: Drug: Multimodal analgesia; Drug: Conventional intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative MCP-1
serum level of MCP-1
Measured: 1-hour before surgery
Preoperative BDNF
serum level of BDNF
Measured: 1-hour before surgery
Preoperative MiRNA-124
serum level of MiRNA-124
Measured: 1-hour before surgery
Postoperative MCP-1
serum level of MCP-1
Measured: 48-hours after surgery
Postoperative BDNF
serum level of BDNF
Measured: 48-hours after surgery
Postoperative MiRNA-124
serum level of MiRNA-124
Measured: 48-hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start15 Oct 2021
- Primary completion30 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ryalino, MD, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069311
- Sponsor's protocol ID
- UNUD-CTR-FK240921-001
- Status last verified
- Aug 2022
- First submitted
- 23 Sep 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05069311
- Acronym / sponsor ID
- UNUD-CTR-FK240921-001
- Conditions
- Inflammation, Inflammatory Response, Acute Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hysterectomy | Experimental | Drug: Multimodal analgesia, Drug: Conventional intravenous analgesiaPatients who undergo surgical hysterectomy that fits inclusion and exclusion criteria |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for elective hysterectomy
- American Society of Anesthesiologists (ASA) physical status 1 to 3
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal analgesiaAlso: Group MMultimodal 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 | Drug | Hysterectomy |
| Conventional intravenous analgesiaAlso: Group CStandard analgesia includes fentanyl 2 mcg/kg (bolus) and morphine given by PCA (patient-controlled analgesia) at 1 mg/dose | Drug | Hysterectomy |
Primary outcome
Preoperative MCP-1
Time frame: 1-hour before surgery
serum level of MCP-1
Preoperative BDNF
Time frame: 1-hour before surgery
serum level of BDNF
Preoperative MiRNA-124
Time frame: 1-hour before surgery
serum level of MiRNA-124
Postoperative MCP-1
Time frame: 48-hours after surgery
serum level of MCP-1
Postoperative BDNF
Time frame: 48-hours after surgery
serum level of BDNF
Postoperative MiRNA-124
Time frame: 48-hours after surgery
serum level of MiRNA-124
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Inflammation
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingPhase 1/2
Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease
Alzheimer Dementia (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal analgesia and Conventional intravenous analgesia in people with Inflammation and Inflammatory Response, run by Udayana University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative MCP-1 (time frame: 1-hour before surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.