search
Back to results

Regional Anesthesia in Breast Surgery

Primary Purpose

Breast Neoplasms, Pain, Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Regional anesthesia
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Analgesia nociceptive index, Surgical pleth index

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology, Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Regional anesthesia

No Regional anesthesia

Arm Description

Regional block applied according to surgical area

No regional anesthesia applied

Outcomes

Primary Outcome Measures

Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Post-operative opioid use
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent

Secondary Outcome Measures

Intra-operative opioid use
Total dose of intra-operative remifentanil
Intra-operative analgesia nociception index
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
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
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
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
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
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
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
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
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
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level

Full Information

First Posted
November 3, 2020
Last Updated
November 9, 2020
Sponsor
Taipei Veterans General Hospital, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT04629612
Brief Title
Regional Anesthesia in Breast Surgery
Official Title
Regional Anesthesia in Non-intubated Breast Surgery, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Pain, Analgesia, Regional Anesthesia
Keywords
Analgesia nociceptive index, Surgical pleth index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regional anesthesia
Arm Type
Experimental
Arm Description
Regional block applied according to surgical area
Arm Title
No Regional anesthesia
Arm Type
No Intervention
Arm Description
No regional anesthesia applied
Intervention Type
Procedure
Intervention Name(s)
Regional anesthesia
Intervention Description
Regional anesthesia such as paravertebral block, pectoral block, superficial cervical plexus block, etc applies according to institution protocol
Primary Outcome Measure Information:
Title
Post-operative opioid use
Description
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Time Frame
From start of post operative care unit to discharge from post operative care unit, up to two hours
Title
Post-operative opioid use
Description
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Time Frame
Second to 12th hour postoperatively
Title
Post-operative opioid use
Description
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Time Frame
12th to 24th hour postoperatively
Title
Post-operative opioid use
Description
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Time Frame
24th to 36th hour postoperatively
Title
Post-operative opioid use
Description
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Time Frame
36th to 48th hour postoperatively
Title
Post-operative opioid use
Description
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Time Frame
48th to 60th hour postoperatively
Title
Post-operative opioid use
Description
Total dose of post-operative morphine, tramadol, meperidine, etc calculated as morphine equivalent
Time Frame
60th to 72nd hour postoperatively
Secondary Outcome Measure Information:
Title
Intra-operative opioid use
Description
Total dose of intra-operative remifentanil
Time Frame
From start of induction to completion of surgery, total of 1-2 hours
Title
Intra-operative analgesia nociception index
Description
Intra-operative measurement of analgesia nociception index, on a scale on 0-100, higher on the scale indicate higher parasympathetic tone
Time Frame
From start of induction to completion of surgery, total of 1-2 hours
Title
Intra-operative surgical pleth index
Description
Intra-operative measurement of surgical pleth index, on a scale on 0-100, lower on the scale indicate higher parasympathetic tone
Time Frame
From start of induction to completion of surgery, total of 1-2 hours
Title
Post-operative nurse rated pain scale
Description
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Time Frame
Second postoperative hour
Title
Post-operative nurse rated pain scale
Description
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Time Frame
6th postoperative hour
Title
Post-operative nurse rated pain scale
Description
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Time Frame
12th postoperative hour
Title
Post-operative nurse rated pain scale
Description
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Time Frame
24th postoperative hour
Title
Post-operative nurse rated pain scale
Description
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Time Frame
36th postoperative hour
Title
Post-operative nurse rated pain scale
Description
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Time Frame
48th postoperative hour
Title
Post-operative nurse rated pain scale
Description
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Time Frame
60th postoperative hour
Title
Post-operative nurse rated pain scale
Description
Post-operative measurement of nurse rated scale, on a scale on 0-10, higher the score indicate higher pain level
Time Frame
72nd postoperative hour

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
On biological representation
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Nung Teng, MD, PhD
Phone
886938593179
Email
weinungteng@gmail.com
Facility Information:
Facility Name
Department of Anesthesiology, Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Regional Anesthesia in Breast Surgery

We'll reach out to this number within 24 hrs