Regional Anesthesia Techniques in Breast Surgery

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.

Participants will undergo one of the following regional anesthesia techniques upon arrival to the surgical suite: paravertebral block, RISS block, PECS II block, intercostal nerve block, serratus anterior plane block, or epidural block. Following regional anesthesia administration, general anesthesia with endotracheal intubation will be performed. Participants' vital signs, postoperative analgesic consumption, and recovery will be recorded.

Conditions

• Augmentation
• Fibroadenoma
• Mastectomy

Interventions

DEVICE

General Anesthesia (GA)

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%.

PROCEDURE

Paravertebral Block (PVB)

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.

PROCEDURE

Rhomboid Intercostal and Subserratus Plane Block (RISS)

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.

PROCEDURE

Pectoral Nerves Block II (PECS II)

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.

PROCEDURE

Intercostal Nerve Block (INB)

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.

PROCEDURE

Serratus Anterior Plane Block (SAPB)

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.

PROCEDURE

Epidural Block

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.

Sponsors & Collaborators

• Xiaguang Duan

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2025-05-01

Completion

2025-05-10

FDA Device

Yes

Countries

• China

Study Locations