Clinical trial NCT04629612: Regional Anesthesia in Breast Surgery
Official title: Regional Anesthesia in Non-intubated Breast Surgery, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Pain
Analgesia
Regional Anesthesia
Keywords: Analgesia nociceptive index
Surgical pleth index
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-11-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Post-operative opioid use
timeFrame: From start of post operative care unit to discharge from post operative care unit, up to two hours
measure: Post-operative opioid use
timeFrame: Second to 12th hour postoperatively
measure: Post-operative opioid use
timeFrame: 12th to 24th hour postoperatively
measure: Post-operative opioid use
timeFrame: 24th to 36th hour postoperatively
measure: Post-operative opioid use
timeFrame: 36th to 48th hour postoperatively
measure: Post-operative opioid use
timeFrame: 48th to 60th hour postoperatively
measure: Post-operative opioid use
timeFrame: 60th to 72nd hour postoperatively
Secondary outcomes:
measure: Intra-operative opioid use
timeFrame: From start of induction to completion of surgery, total of 1-2 hours
measure: Intra-operative analgesia nociception index
timeFrame: From start of induction to completion of surgery, total of 1-2 hours
measure: Intra-operative surgical pleth index
timeFrame: From start of induction to completion of surgery, total of 1-2 hours
measure: Post-operative nurse rated pain scale
timeFrame: Second postoperative hour
measure: Post-operative nurse rated pain scale
timeFrame: 6th postoperative hour
measure: Post-operative nurse rated pain scale
timeFrame: 12th postoperative hour
measure: Post-operative nurse rated pain scale
timeFrame: 24th postoperative hour
measure: Post-operative nurse rated pain scale
timeFrame: 36th postoperative hour
measure: Post-operative nurse rated pain scale
timeFrame: 48th postoperative hour
measure: Post-operative nurse rated pain scale
timeFrame: 60th postoperative hour
measure: Post-operative nurse rated pain scale
timeFrame: 72nd postoperative hour
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, Taipei Veterans General Hospital
Study officials:
References: