Regional Anesthesia in Breast Surgery
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Regional anesthesia Regional block applied according to surgical area |
Procedure: Regional anesthesia
Regional anesthesia such as paravertebral block, pectoral block, superficial cervical plexus block, etc applies according to institution protocol
|
| No Intervention: No Regional anesthesia No regional anesthesia applied |
Outcome Measures
Primary Outcome Measures
- Post-operative opioid use [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 [Second to 12th hour postoperatively]
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
- Post-operative opioid use [12th to 24th hour postoperatively]
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
- Post-operative opioid use [24th to 36th hour postoperatively]
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
- Post-operative opioid use [36th to 48th hour postoperatively]
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
- Post-operative opioid use [48th to 60th hour postoperatively]
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
- Post-operative opioid use [60th to 72nd hour postoperatively]
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Secondary Outcome Measures
- Intra-operative opioid use [From start of induction to completion of surgery, total of 1-2 hours]
Total dose of intra-operative remifentanil
- Intra-operative analgesia nociception index [From start of induction to completion of surgery, total of 1-2 hours]
Intra-operative measurement of analgesia nociception index, on a scale on 0-100, higher on the scale indicate higher parasympathetic tone
- Intra-operative surgical pleth index [From start of induction to completion of surgery, total of 1-2 hours]
Intra-operative measurement of surgical pleth index, on a scale on 0-100, lower on the scale indicate higher parasympathetic tone
- Post-operative nurse rated pain scale [Second postoperative hour]
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
- Post-operative nurse rated pain scale [6th postoperative hour]
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
- Post-operative nurse rated pain scale [12th postoperative hour]
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
- Post-operative nurse rated pain scale [24th postoperative hour]
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
- Post-operative nurse rated pain scale [36th postoperative hour]
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
- Post-operative nurse rated pain scale [48th postoperative hour]
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
- Post-operative nurse rated pain scale [60th postoperative hour]
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
- Post-operative nurse rated pain scale [72nd postoperative hour]
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anesthesiology, Taipei Veterans General Hospital | Taipei | Taiwan | 112 |
Sponsors and Collaborators
- Taipei Veterans General Hospital, Taiwan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-05-001B