Regional Anesthesia in Breast Surgery

Not Applicable

Completed

• Conditions: Pain; Analgesia; Regional Anesthesia; Breast Neoplasms
• Interventions: Procedure: Regional anesthesia

• Registration Number: NCT04629612
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-16
• Study Start: 2020-11-20
• Primary Completion: 2023-02-24
• Study Completion: 2023-03-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regional anesthesia	Regional anesthesia	Regional block applied according to surgical area

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	72nd postoperative hour	Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level

Trial Locations

Locations (1)

Department of Anesthesiology, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan