Regional Anesthesia in Breast Surgery

NCT ID: NCT04629612

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2023-03-02

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.

Conditions

Breast Neoplasms; Pain; Analgesia; Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Regional anesthesia

Regional block applied according to surgical area

Group Type: EXPERIMENTAL

Regional anesthesia

Intervention Type: PROCEDURE

Regional anesthesia such as paravertebral block, pectoral block, superficial cervical plexus block, etc applies according to institution protocol

No Regional anesthesia

No regional anesthesia applied

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Regional anesthesia

Regional anesthesia such as paravertebral block, pectoral block, superficial cervical plexus block, etc applies according to institution protocol

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2020-05-001B

Identifier Type: -

Identifier Source: org_study_id