Anesthesia, LocalNCT04540055
General Anesthesia and Paravertebral Blocks vs. General Anesthesia Only: Influence Inflammation Factors and Clinical Outcomes in Modified Radical Mastectomy
An observational study of Anesthesia, Local and Anesthesia, run by Udayana University at 1 site in Indonesia.
Trial summary
Regional anesthesia and analgesia may maintain immune function, reduce surgical stress, and also reduce volatile anesthetics and opioids requirements. Local anesthetic drugs used in regional anesthesia and analgesia work to have anti-proliferative and cytotoxic effects on cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia, Local, Anesthesia, Inflammatory Response
- What is being tested?
- Paravertebral block and General Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2020to 21 Jan 2021
- Phase
- Observational
- 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
Study population: Patients with breast cancer (stadium Ia-IIIb) who underwent MRM surgery under general anesthesia in Sanglah General Hospital
Who may be able to join
- Patient with breast cancer (stadium Ia, Ib, IIa, IIb, IIIa, IIIb) undergoing MRM surgery
- Balinese race
- ASA physical status I, II, III
Who cannot join
- History of allergy to drugs used in anesthesia
- History psychiatric disorder
- History of perioperative transfusion
- History of autoimmune disease
- History of taking beta blockers or anti-platelet aggregation medications
- Previous breast surgery
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- Spine deformity
- Coagulopathy
- Local infections in paravertebral block site
- Decreased renal function
- Neurological deficits
- Peptic ulcer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of General Anesthesia vs. General Anesthesia and Paravertebral Block to IL-2, IL-6, PGE2, MMP-9, and Clinical Outcome in Modified Radical Mastectomy
Regional anesthesia and analgesia may maintain immune function, reduce surgical stress, and also reduce volatile anesthetics and opioids requirements. Local anesthetic drugs used in regional anesthesia and analgesia work to have anti-proliferative and cytotoxic effects on cancer cells. Pro-inflammatory cytokines such as IL-1, IL-6, and TNF-alpha increase in levels in peripheral nerves, spinal cord, brain (brain stem, locus sereleus, thalamus, hippocampus, and prefrontal cortex) after peripheral nerves are injured. The anti-inflammatory cytokine IL-10 is decreased in levels after peripheral nerve injury. The balance between pro-inflammatory and anti-inflammatory cytokines affects the severity of pain.
- Being tested
- Paravertebral block, General Anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral blockProcedure or surgery
The subjects in this group received general anesthesia and USG-guided paravertebral block
General AnesthesiaProcedure or surgery
The subjects in this group underwent MRM under routine general anesthesia without peripheral nerve block supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral (Group P) | Patients underwent MRM under the combination of general anesthesia and paravertebral block. Receives: Procedure: Paravertebral block | |
| General Anesthesia (Group G) | Patients underwent MRM under general anesthesia. Receives: Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of IL-2 in blood serum
Concentration of IL-2 level in blood serum
Measured: 1-hour after surgery
Concentration of IL-2 in blood serum
Concentration of IL-2 level in blood serum
Measured: 24-hours after surgery
Concentration of IL-6 in blood serum
Concentration of IL-6 level in blood serum
Measured: 1-hour after surgery
Concentration of IL-6 in blood serum
Concentration of IL-6 level in blood serum
Measured: 24-hours after surgery
Visual Analog Scale (VAS)
pain score measured by visual analog scale (VAS), scaled between 0 (no pain) and 10 (worst pain)
Measured: 24-hours after surgery
Secondary outcomes (4)
Concentration of PGE2 level in blood serum
Concentration of PGE2 level in blood serum
Measured: 1-hour after surgery
Concentration of PGE2 level in blood serum
Concentration of PGE2 level in blood serum
Measured: 24-hours after surgery
Concentration of MMP-9 level in blood serum
Concentration of MMP-9 level in blood serum
Measured: 1-hour after surgery
Concentration of MMP-9 level in blood serum
Concentration of MMP-9 level in blood serum
Measured: 24-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 posted7 Sep 2020
- Study start1 Oct 2020
- Primary completion30 Dec 2020
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ryalino, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540055
- Sponsor's protocol ID
- UNUD-CTR-FK300820-004
- Status last verified
- Jan 2021
- First submitted
- 31 Aug 2020
- Last updated
- 22 Jan 2021
- 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 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of General Anesthesia vs. General Anesthesia and Paravertebral Block to IL-2, IL-6, PGE2, MMP-9, and Clinical Outcome in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT04540055
- Acronym / sponsor ID
- UNUD-CTR-FK300820-004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 7 Sep 2020 (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.
Regional anesthesia and analgesia may maintain immune function, reduce surgical stress, and also reduce volatile anesthetics and opioids requirements. Local anesthetic drugs used in regional anesthesia and analgesia work to have anti-proliferative and cytotoxic effects on cancer cells. Pro-inflammatory cytokines such as IL-1, IL-6, and TNF-alpha increase in levels in peripheral nerves, spinal cord, brain (brain stem, locus sereleus, thalamus, hippocampus, and prefrontal cortex) after peripheral nerves are injured. The anti-inflammatory cytokine IL-10 is decreased in levels after peripheral nerve injury. The balance between pro-inflammatory and anti-inflammatory cytokines affects the severity of pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral (Group P) | – | Procedure: Paravertebral blockPatients underwent MRM under the combination of general anesthesia and paravertebral block. |
| General Anesthesia (Group G) | – | Procedure: General AnesthesiaPatients underwent MRM under general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer (stadium Ia-IIIb) who underwent MRM surgery under general anesthesia in Sanglah General Hospital
Key inclusion criteria (3 listed)
- Patient with breast cancer (stadium Ia, Ib, IIa, IIb, IIIa, IIIb) undergoing MRM surgery
- Balinese race
- ASA physical status I, II, III
Key exclusion criteria (12 listed)
- History of allergy to drugs used in anesthesia
- History psychiatric disorder
- History of perioperative transfusion
- History of autoimmune disease
- History of taking beta blockers or anti-platelet aggregation medications
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 |
|---|---|---|
| Paravertebral blockThe subjects in this group received general anesthesia and USG-guided paravertebral block | Procedure or surgery | Paravertebral (Group P) |
| General AnesthesiaThe subjects in this group underwent MRM under routine general anesthesia without peripheral nerve block supplementation. | Procedure or surgery | General Anesthesia (Group G) |
Primary outcome
Concentration of IL-2 in blood serum
Time frame: 1-hour after surgery
Concentration of IL-2 level in blood serum
Concentration of IL-2 in blood serum
Time frame: 24-hours after surgery
Concentration of IL-2 level in blood serum
Concentration of IL-6 in blood serum
Time frame: 1-hour after surgery
Concentration of IL-6 level in blood serum
Concentration of IL-6 in blood serum
Time frame: 24-hours after surgery
Concentration of IL-6 level in blood serum
Visual Analog Scale (VAS)
Time frame: 24-hours after surgery
pain score measured by visual analog scale (VAS), scaled between 0 (no pain) and 10 (worst pain)
4 secondary outcomes
Concentration of PGE2 level in blood serum
Time frame: 1-hour after surgery
Concentration of PGE2 level in blood serum
Time frame: 24-hours after surgery
Concentration of MMP-9 level in blood serum
Time frame: 1-hour after surgery
Concentration of MMP-9 level in blood serum
Time frame: 24-hours after surgery
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 22 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Anesthesia, Local and Anesthesia, 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 3 inclusion and 12 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 22 Jan 2021. 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?
Concentration of IL-2 in blood serum (time frame: 1-hour after surgery). The study lists 5 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 22 Jan 2021.