Regional Anesthesia Techniques in Breast Surgery
1 other identifier
interventional
180
1 country
1
Brief Summary
This clinical trial aims to evaluate the efficacy of liposomal bupivacaine and ropivacaine, when administered via paravertebral block, the rhomboid intercostal and subserratus plane (RISS) block, PECS II block, intercostal nerve block, serratus anterior plane block, or epidural block, in patients undergoing breast surgery (including augmentation, fibroadenoma excision, and mastectomy). The primary objectives are to determine:
- 1.Whether the use of liposomal bupivacaine or ropivacaine reduces the postoperative analgesic requirements in participants.
- 2.What potential adverse events participants experience when using liposomal bupivacaine or ropivacaine.
- 3.Which of the following regional anesthesia techniques provides superior analgesia: paravertebral block, RISS block, PECS II block, intercostal nerve block, serratus anterior plane block, or epidural block.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2025
CompletedFirst Posted
Study publicly available on registry
January 16, 2025
CompletedStudy Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2025
CompletedJanuary 17, 2025
January 1, 2025
3 months
January 13, 2025
January 16, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Numerical Rating Scale(NRS)
The NRS, Numerical Rating Scale, is a rating system from 0 to 10, where 0 represents "no pain" and 10 represents the worst possible pain.
At baseline (before therapy),At 2hours post-surgery, At 6hours post-surgery、At 12hours post-surgery、At 24hours post-surgery.
Total Analgesic Consumption within 24 Hours Post-Surgery
The total amount of all analgesic medications (including opioids such as fentanyl and morphine, and non-steroidal anti-inflammatory drugs such as ibuprofen and acetaminophen) used by the patient within the first 24 hours following surgery will be recorded. These dosages will be converted to their equivalent morphine milligram (mg) dose. Higher total morphine equivalent doses will indicate a lower level of analgesia efficacy.
At baseline (in operation),At 2hours post-surgery, At 6hours post-surgery、At 12hours post-surgery、At 24hours post-surgery.
Secondary Outcomes (2)
Patient Satisfaction Score
At 24 hours post-surgery
Postoperative Recovery Status
Assessments will be performed at 6 hours, 12 hours, and 24 hours post-surgery, with a final assessment prior to hospital discharge.
Study Arms (6)
Paravertebral Block (PVB)
EXPERIMENTALThe patient will be positioned in the lateral decubitus position with the operative side up. A high-frequency ultrasound probe (6-13 MHz) will be used to visualize the transverse processes, ribs, and pleura adjacent to the thoracic transverse processes on the operative side. Under ultrasound guidance, a needle will be inserted from posterior to anterior, advancing just superior to the tip of the transverse process, 1-2 mm, avoiding the pleura, and entering the paravertebral space. For ropivacaine, either 0.375% or 0.5% will be administered at a dose of 3-5 mL per segment, according to the patient's height and the extent of surgery. The block will target the T2-T6 nerve distribution, with a total dose not exceeding 20 mL. Alternatively, for liposomal bupivacaine (10-26.6 mg/mL), the dose will be determined based on the patient's weight and surgical extent, typically a total dose of 100-200 mg, diluted with normal saline to a total injection volume of 10-20 mL.
Rhomboid Intercostal and Subserratus Plane Block (RISS)
EXPERIMENTALThe patient will be positioned in the lateral decubitus position with the operative side up. A high-frequency ultrasound probe will be used to locate the medial border of the scapula and identify the rhomboid, intercostal, and serratus anterior muscles. Under ultrasound guidance, the needle will be advanced into the plane between the rhomboid and intercostal muscles, or the plane between the intercostal and serratus anterior muscles. Ropivacaine 0.25% will be administered with an injection volume of 15-20 mL. Alternatively, liposomal bupivacaine (10-26.6 mg/mL) will be administered according to the manufacturer's recommended dosage, usually a total dose of 100-200 mg, with an injection volume of 15-20 mL.
Pectoral Nerves Block II (PECS II)
EXPERIMENTALThe patient will be placed in the supine position with the operative side arm slightly abducted. A high-frequency ultrasound probe will be used to locate the pectoralis major, pectoralis minor, and serratus anterior muscles. Under ultrasound guidance, the needle will be advanced into the plane between the pectoralis minor and serratus anterior muscles. Ropivacaine 0.25% will be administered with an injection volume of 20-30 mL. Alternatively, liposomal bupivacaine (10-26.6 mg/mL) will be administered according to the manufacturer's recommended dosage, usually a total dose of 100-200 mg, with an injection volume of 20-30 mL.
Intercostal Nerve Block (INB)
EXPERIMENTALThe patient will be positioned in the lateral decubitus or supine position. A high-frequency ultrasound probe will be used to locate the ribs and intercostal muscles. Under ultrasound guidance, the needle will be advanced to the inferior margin of the rib, in the intercostal muscle plane. Ropivacaine 0.25% will be administered at a dose of 2-5 mL per intercostal space, typically targeting 3-5 intercostal spaces. Alternatively, liposomal bupivacaine (10-26.6 mg/mL) will be administered at a dose of 2-5 mL per intercostal space, with a total dose not exceeding 200 mg, and a total injection volume of 5-20 mL.
Serratus Anterior Plane Block (SAPB)
EXPERIMENTALThe patient will be positioned in the lateral decubitus or supine position with the operative side arm slightly abducted. A high-frequency ultrasound probe will be used to locate the serratus anterior muscle. Under ultrasound guidance, the needle will be advanced either superficial or deep to the serratus anterior muscle. Ropivacaine 0.25% will be administered with an injection volume of 20-30 mL. Alternatively, liposomal bupivacaine (10-26.6 mg/mL) will be administered according to the manufacturer's recommended dosage, usually a total dose of 100-200 mg, with an injection volume of 20-30 mL.
Epidural Block
EXPERIMENTALThe patient will be positioned in the sitting or lateral decubitus position. The area will be prepped and draped using standard aseptic technique. Either the thoracic or lumbar region will be selected, with the T4-T5 level often chosen. An epidural needle will be inserted into the epidural space, and an epidural catheter will be placed, using standard epidural techniques. Ropivacaine 0.1% or 0.083% will be administered as an initial bolus of 5-10 mL, followed by a continuous infusion at a rate of 5-10 mL/h. Alternatively, bupivacaine 0.1% or 0.0625% will be administered as an initial bolus of 5-10 mL, followed by a continuous infusion at a rate of 5-10 mL/h. These can be used in combination with opioid medications such as fentanyl or sufentanil to enhance analgesia.
Interventions
Following administration of the regional anesthesia, general anesthesia with endotracheal intubation will be performed. Anesthesia induction will be achieved using propofol (1.5-2 mg/kg i.v.), rocuronium (1-2 mg/kg i.v.), and fentanyl (1-2 μg/kg i.v.). Anesthesia will be maintained using sevoflurane or desflurane, with inhaled concentration adjusted based on Bispectral Index (BIS) monitoring. A continuous infusion of remifentanil (0.05-0.2 μg/kg/min) will be administered, with adjustments to maintain blood pressure and heart rate within ±20% of baseline values. Following induction, patients will be mechanically ventilated in pressure-regulated volume control (PRVC) mode. The ventilator (Aestiva; GE Healthcare, Waukesha, Wisconsin, USA) settings will be: tidal volume 6-8 mL/kg, positive end-expiratory pressure 0 cm H2O, inspiratory to expiratory ratio 1:2, respiratory rate 16 breaths per minute (BPM), and fraction of inspired oxygen 41%.
The patient will be positioned in the lateral decubitus position with the operative side up. A high-frequency ultrasound probe (6-13 MHz) will be used to visualize the transverse processes, ribs, and pleura adjacent to the thoracic transverse processes on the operative side. Under ultrasound guidance, a needle will be inserted from posterior to anterior, advancing just superior to the tip of the transverse process, 1-2 mm, avoiding the pleura, and entering the paravertebral space. For ropivacaine, either 0.375% or 0.5% will be administered at a dose of 3-5 mL per segment, according to the patient's height and the extent of surgery. The block will target the T2-T6 nerve distribution, with a total dose not exceeding 20 mL. Alternatively, for liposomal bupivacaine (10-26.6 mg/mL), the dose will be determined based on the patient's weight and surgical extent, typically a total dose of 100-200 mg, diluted with normal saline to a total injection volume of 10-20 mL.
The patient will be positioned in the lateral decubitus position with the operative side up. A high-frequency ultrasound probe will be used to locate the medial border of the scapula and identify the rhomboid, intercostal, and serratus anterior muscles. Under ultrasound guidance, the needle will be advanced into the plane between the rhomboid and intercostal muscles, or the plane between the intercostal and serratus anterior muscles. Ropivacaine 0.25% will be administered with an injection volume of 15-20 mL. Alternatively, liposomal bupivacaine (10-26.6 mg/mL) will be administered according to the manufacturer's recommended dosage, usually a total dose of 100-200 mg, with an injection volume of 15-20 mL.
The patient will be placed in the supine position with the operative side arm slightly abducted. A high-frequency ultrasound probe will be used to locate the pectoralis major, pectoralis minor, and serratus anterior muscles. Under ultrasound guidance, the needle will be advanced into the plane between the pectoralis minor and serratus anterior muscles. Ropivacaine 0.25% will be administered with an injection volume of 20-30 mL. Alternatively, liposomal bupivacaine (10-26.6 mg/mL) will be administered according to the manufacturer's recommended dosage, usually a total dose of 100-200 mg, with an injection volume of 20-30 mL.
The patient will be positioned in the lateral decubitus or supine position. A high-frequency ultrasound probe will be used to locate the ribs and intercostal muscles. Under ultrasound guidance, the needle will be advanced to the inferior margin of the rib, in the intercostal muscle plane. Ropivacaine 0.25% will be administered at a dose of 2-5 mL per intercostal space, typically targeting 3-5 intercostal spaces. Alternatively, liposomal bupivacaine (10-26.6 mg/mL) will be administered at a dose of 2-5 mL per intercostal space, with a total dose not exceeding 200 mg, and a total injection volume of 5-20 mL.
The patient will be positioned in the lateral decubitus or supine position with the operative side arm slightly abducted. A high-frequency ultrasound probe will be used to locate the serratus anterior muscle. Under ultrasound guidance, the needle will be advanced either superficial or deep to the serratus anterior muscle. Ropivacaine 0.25% will be administered with an injection volume of 20-30 mL. Alternatively, liposomal bupivacaine (10-26.6 mg/mL) will be administered according to the manufacturer's recommended dosage, usually a total dose of 100-200 mg, with an injection volume of 20-30 mL.
The patient will be positioned in the sitting or lateral decubitus position. The area will be prepped and draped using standard aseptic technique. Either the thoracic or lumbar region will be selected, with the T4-T5 level often chosen. An epidural needle will be inserted into the epidural space, and an epidural catheter will be placed, using standard epidural techniques. Ropivacaine 0.1% or 0.083% will be administered as an initial bolus of 5-10 mL, followed by a continuous infusion at a rate of 5-10 mL/h. Alternatively, bupivacaine 0.1% or 0.0625% will be administered as an initial bolus of 5-10 mL, followed by a continuous infusion at a rate of 5-10 mL/h. These can be used in combination with opioid medications such as fentanyl or sufentanil to enhance analgesia.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Age of 18 years or older.
- Scheduled to undergo breast surgery, including augmentation, fibroadenoma excision, or mastectomy.
You may not qualify if:
- Known allergy to local anesthetics.
- Pregnancy or lactation.
- Coagulation disorders.
- Severe cardiopulmonary disease.
- Local infection at the injection site.
- Unstable psychiatric illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiaguang Duanlead
Study Sites (1)
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, 014010, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Deputy Chief of Anesthesiology
Study Record Dates
First Submitted
January 13, 2025
First Posted
January 16, 2025
Study Start
February 1, 2025
Primary Completion
May 1, 2025
Study Completion
May 10, 2025
Last Updated
January 17, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- January 2026-January 2031
- Access Criteria
- A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.