Regional Anesthesia in Breast Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Regional Anesthesia in Non-intubated Breast Surgery, a Randomized Controlled Trial

Conditions
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Breast Neoplasms, Pain, Analgesia, Regional Anesthesia

Intervention / Treatment
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* Procedure: Regional anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast neoplasm require surgical resection of tumor Surgical type: non-intubated breast surgery under intravenous anesthesia Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regional anesthesia<br>Regional block applied according to surgical area | Procedure: Regional anesthesia<br>* Regional anesthesia such as paravertebral block, pectoral block, superficial cervical plexus block, etc applies according to institution protocol<br>|
| No Intervention: No Regional anesthesia<br>No regional anesthesia applied | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative opioid use | Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent | 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 | Second to 12th hour postoperatively | 
| Post-operative opioid use | Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent | 12th to 24th hour postoperatively | 
| Post-operative opioid use | Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent | 24th to 36th hour postoperatively | 
| Post-operative opioid use | Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent | 36th to 48th hour postoperatively | 
| Post-operative opioid use | Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent | 48th to 60th hour postoperatively | 
| Post-operative opioid use | Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent | 60th to 72nd hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative opioid use | Total dose of intra-operative remifentanil | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 72nd postoperative hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia nociceptive index, Surgical pleth index