Breast NeoplasmsNCT04629612
Regional Anesthesia in Breast Surgery
A study testing Regional anesthesia in people with Breast Neoplasms and Pain, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
There is a trend that breast surgery can be done with peripheral nerve blockade and intravenous sedation, which reduces the side effects of general anesthesia such as nausea and vomiting, intubation discomfort and postoperative pain. The distribution of breast nerves is complex. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms, Pain, Analgesia
- What is being tested?
- Regional anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Nov 2020to 2 Mar 2023
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast neoplasm require surgical resection of tumor
- Surgical type: non-intubated breast surgery under intravenous anesthesia
Who cannot join
- Contraindication for regional anesthesia: coagulopathy, infection
- Previous breast surgery
- Body mass index > 40
- Chronic opioid use
- Allergy to intravenous and regional anesthesia agents: Propofol, remifentanil, bupivacaine
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: Regional Anesthesia in Non-intubated Breast Surgery, a Randomized Controlled Trial
There is a trend that breast surgery can be done with peripheral nerve blockade and intravenous sedation, which reduces the side effects of general anesthesia such as nausea and vomiting, intubation discomfort and postoperative pain. The distribution of breast nerves is complex. Common nerve block methods are paravertebral blocks and pectoral nerve blocks. By monitoring the patient's heart rate variability change and measuring the patient's parasympathetic tone, the analgesic drug can be administered according to the patient's individual differences to avoid insufficient or excessive analgesic dose. The aim of this proposal is a prospective randomized controlled clinical trial is designed to evaluate changes in analgesia nociception index (ANI), surgical pleth index (SPI), postoperative opioid demand, and pain scores between patients who received regional anesthesia and those without in breast surgery patients under non-intubated surgery.
Read the detailed description
Anesthesia has three elements: immobility, painlessness, and amnesia. To achieve these three factors depends on the balance between multiple factors, so multiple parameters need to be used for evaluation. In terms of subcortical function, pain indexes such as analgesia nociception index, surgical pleth index, etc. can be used to evaluate. By monitoring the parameters and comprehensive evaluation during the operation, the patient's condition can be fully understood. Opioids act on the central nervous system, making the nerve response slow and analgesic The effect is good, but there are many side effects, such as nausea and vomiting, drowsiness, respiratory depression, constipation, endocrine disorders, etc., and the central nervous system is suppressed by opioids, but the surrounding tissues are still damaged, releasing inflammatory mediators, causing immune dysfunction. Therefore, it is necessary to suppress inflammation and reduce the use of opioids, but also to effectively relieve pain. Nerve blockade is a powerful tool for this purpose. Local anesthetics are applied next to the nerves of the wound so that the pain signal cannot be transmitted to the central nervous system, reduce inflammatory mediators, reduce acute and chronic pain.
Breast surgery can be completed by peripheral nerve blockade and intravenous sedation, which can reduce the side effects of general anesthesia such as nausea and vomiting, intubation discomfort and postoperative pain. The distribution of breast nerves is complex, from the superficial cervical plexus, brachial nerve plexus, and thoracic vertebral nerves. At present, the commonly used nerve blocking methods include spinal nerve block, thoracic muscle block, brachial nerve block, and superficial nerve block. Blocking methods such as the cervical plexus, studies have shown that peripheral nerve blockade can reduce the amount of opioid analgesics during surgery.
This research plan is to design a randomized clinical trial to observe changes in the analgesic injury index (ANI), surgical pleth index (SPI), intraoperative and postoperative opiate demand, pain index, etc. inpatients with or without regional anesthesia under non-intubated breast surgery.
- Conditions
- Breast Neoplasms, Pain, Analgesia, Regional Anesthesia
- Being tested
- Regional anesthesia
- Keywords
- Analgesia nociceptive index, Surgical pleth index
- Medical subject headings
- Breast Neoplasms, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesiaProcedure or surgery
Regional anesthesia such as paravertebral block, pectoral block, superficial cervical plexus block, etc applies according to institution protocol
| Study group | Role | What they receive |
|---|---|---|
| Regional anesthesia | Experimental | Regional block applied according to surgical area Receives: Procedure: Regional anesthesia |
| No Regional anesthesia | No intervention | No regional anesthesia applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Measured: From start of post operative care unit to discharge from post operative care unit, up to two hours
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Measured: Second to 12th hour postoperatively
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Measured: 12th to 24th hour postoperatively
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Measured: 24th to 36th hour postoperatively
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Measured: 36th to 48th hour postoperatively
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Measured: 48th to 60th hour postoperatively
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Measured: 60th to 72nd hour postoperatively
Secondary outcomes (11)
Intra-operative opioid use
Total dose of intra-operative remifentanil
Measured: From start of induction to completion of surgery, total of 1-2 hours
Intra-operative analgesia nociception index
Intra-operative measurement of analgesia nociception index, on a scale on 0-100, higher on the scale indicate higher parasympathetic tone
Measured: From start of induction to completion of surgery, total of 1-2 hours
Intra-operative surgical pleth index
Intra-operative measurement of surgical pleth index, on a scale on 0-100, lower on the scale indicate higher parasympathetic tone
Measured: From start of induction to completion of surgery, total of 1-2 hours
Post-operative nurse rated pain scale
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Measured: Second postoperative hour
Post-operative nurse rated pain scale
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Measured: 6th postoperative hour
Post-operative nurse rated pain scale
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Measured: 12th postoperative hour
Post-operative nurse rated pain scale
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Measured: 24th postoperative hour
Post-operative nurse rated pain scale
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Measured: 36th postoperative hour
Post-operative nurse rated pain scale
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Measured: 48th postoperative hour
Post-operative nurse rated pain scale
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Measured: 60th postoperative hour
Post-operative nurse rated pain scale
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Measured: 72nd postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start20 Nov 2020
- Primary completion24 Feb 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629612
- Sponsor's protocol ID
- 2020-05-001B
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2020
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia in Non-intubated Breast Surgery, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04629612
- Acronym / sponsor ID
- 2020-05-001B
- Conditions
- Breast Neoplasms, Pain, Analgesia, Regional Anesthesia
- Keywords
- Analgesia nociceptive index, Surgical pleth index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 16 Nov 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.
There is a trend that breast surgery can be done with peripheral nerve blockade and intravenous sedation, which reduces the side effects of general anesthesia such as nausea and vomiting, intubation discomfort and postoperative pain. The distribution of breast nerves is complex. Common nerve block methods are paravertebral blocks and pectoral nerve blocks. By monitoring the patient's heart rate variability change and measuring the patient's parasympathetic tone, the analgesic drug can be administered according to the patient's individual differences to avoid insufficient or excessive analgesic dose. The aim of this proposal is a prospective randomized controlled clinical trial is designed to evaluate changes in analgesia nociception index (ANI), surgical pleth index (SPI), postoperative opioid demand, and pain scores between patients who received regional anesthesia and those without in breast surgery patients under non-intubated surgery.
Detailed description
Anesthesia has three elements: immobility, painlessness, and amnesia. To achieve these three factors depends on the balance between multiple factors, so multiple parameters need to be used for evaluation. In terms of subcortical function, pain indexes such as analgesia nociception index, surgical pleth index, etc. can be used to evaluate. By monitoring the parameters and comprehensive evaluation during the operation, the patient's condition can be fully understood. Opioids act on the central nervous system, making the nerve response slow and analgesic The effect is good, but there are many side effects, such as nausea and vomiting, drowsiness, respiratory depression, constipation, endocrine disorders, etc., and the central nervous system is suppressed by opioids, but the surrounding tissues are still damaged, releasing inflammatory mediators, causing immune dysfunction. Therefore, it is necessary to suppress inflammation and reduce the use of opioids, but also to effectively relieve pain. Nerve blockade is a powerful tool for this purpose. Local anesthetics are applied next to the nerves of the wound so that the pain signal cannot be transmitted to the central nervous system, reduce inflammatory mediators, reduce acute and chronic pain.
Breast surgery can be completed by peripheral nerve blockade and intravenous sedation, which can reduce the side effects of general anesthesia such as nausea and vomiting, intubation discomfort and postoperative pain. The distribution of breast nerves is complex, from the superficial cervical plexus, brachial nerve plexus, and thoracic vertebral nerves. At present, the commonly used nerve blocking methods include spinal nerve block, thoracic muscle block, brachial nerve block, and superficial nerve block. Blocking methods such as the cervical plexus, studies have shown that peripheral nerve blockade can reduce the amount of opioid analgesics during surgery.
This research plan is to design a randomized clinical trial to observe changes in the analgesic injury index (ANI), surgical pleth index (SPI), intraoperative and postoperative opiate demand, pain index, etc. inpatients with or without regional anesthesia under non-intubated breast surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional anesthesia | Experimental | Procedure: Regional anesthesiaRegional block applied according to surgical area |
| No Regional anesthesia | No intervention | –No regional anesthesia applied |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Breast neoplasm require surgical resection of tumor
- Surgical type: non-intubated breast surgery under intravenous anesthesia
Key exclusion criteria (5 listed)
- Contraindication for regional anesthesia: coagulopathy, infection
- Previous breast surgery
- Body mass index > 40
- Chronic opioid use
- Allergy to intravenous and regional anesthesia agents: Propofol, remifentanil, bupivacaine
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 |
|---|---|---|
| Regional anesthesiaRegional anesthesia such as paravertebral block, pectoral block, superficial cervical plexus block, etc applies according to institution protocol | Procedure or surgery | Regional anesthesia |
Primary outcome
Post-operative opioid use
Time frame: From start of post operative care unit to discharge from post operative care unit, up to two hours
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Time frame: Second to 12th hour postoperatively
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Time frame: 12th to 24th hour postoperatively
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Time frame: 24th to 36th hour postoperatively
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Time frame: 36th to 48th hour postoperatively
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Time frame: 48th to 60th hour postoperatively
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Time frame: 60th to 72nd hour postoperatively
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
11 secondary outcomes
Intra-operative opioid use
Time frame: From start of induction to completion of surgery, total of 1-2 hours
Intra-operative analgesia nociception index
Time frame: From start of induction to completion of surgery, total of 1-2 hours
Intra-operative surgical pleth index
Time frame: From start of induction to completion of surgery, total of 1-2 hours
Post-operative nurse rated pain scale
Time frame: Second postoperative hour
Post-operative nurse rated pain scale
Time frame: 6th postoperative hour
Post-operative nurse rated pain scale
Time frame: 12th postoperative hour
Post-operative nurse rated pain scale
Time frame: 24th postoperative hour
Post-operative nurse rated pain scale
Time frame: 36th postoperative hour
Post-operative nurse rated pain scale
Time frame: 48th postoperative hour
Post-operative nurse rated pain scale
Time frame: 60th postoperative hour
Post-operative nurse rated pain scale
Time frame: 72nd postoperative hour
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 14 Aug 2024.
- Individual participant dataSharing planned: No
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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?
A study testing Regional anesthesia in people with Breast Neoplasms and Pain, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 5 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 14 Aug 2024. 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 Taiwan. 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?
Post-operative opioid use (time frame: From start of post operative care unit to discharge from post operative care unit, up to two hours). The study lists 7 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 14 Aug 2024.