Regional Anesthesia in Breast Surgery

NCT04629612 | Completed

• 1 other identifier: 2020-05-001B
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Pain; Analgesia; Regional Anesthesia

Keywords

Analgesia nociceptive index; Surgical pleth index

Outcome Measures

Primary Outcomes (7)

• Post-operative opioid use

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

  From start of post operative care unit to discharge from post operative care unit, up to two hours

• Post-operative opioid use

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

  Second to 12th hour postoperatively

• Post-operative opioid use

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

  12th to 24th hour postoperatively

• Post-operative opioid use

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

  24th to 36th hour postoperatively

• Post-operative opioid use

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

  36th to 48th hour postoperatively

• Post-operative opioid use

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

  48th to 60th hour postoperatively

• Post-operative opioid use

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

  60th to 72nd hour postoperatively

Secondary Outcomes (11)

• Intra-operative opioid use

  From start of induction to completion of surgery, total of 1-2 hours

• Intra-operative analgesia nociception index

  From start of induction to completion of surgery, total of 1-2 hours

• Intra-operative surgical pleth index

  From start of induction to completion of surgery, total of 1-2 hours

• Post-operative nurse rated pain scale

  Second postoperative hour

• Post-operative nurse rated pain scale

  6th postoperative hour

Study Arms (2)

Regional anesthesia

EXPERIMENTAL

Regional block applied according to surgical area

Procedure: Regional anesthesia

No Regional anesthesia

NO INTERVENTION

No regional anesthesia applied

Interventions

Regional anesthesia PROCEDURE

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

Regional anesthesia

Eligibility Criteria

• Age: 20 Years - 80 Years
• Gender Eligibility Details: On biological representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast neoplasm require surgical resection of tumor
• Surgical type: non-intubated breast surgery under intravenous anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain; Agnosia

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 16, 2020
• Study Start: November 20, 2020
• Primary Completion: February 24, 2023
• Study Completion: March 2, 2023
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)