Analgesia, Breast Neoplasms, Pain, Regional Anesthesia
Conditions
Keywords
Analgesia nociceptive index, Surgical pleth index
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.
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.
Interventions
PROCEDURERegional anesthesia
Regional anesthesia such as paravertebral block, pectoral block, superficial cervical plexus block, etc applies according to institution protocol
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed