Regional Anesthesia Techniques in Breast Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorXiaguang Duan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known allergy to local anesthetics.
Pregnancy or lactation.
Coagulation disorders.
Severe cardiopulmonary disease.
Trial design
Design model
Parallel
Treatments tested in this trial
General Anesthesia (GA)
DeviceFollowing 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%.
Paravertebral Block (PVB)
Procedure/SurgeryThe 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)
Procedure/SurgeryThe 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)
Procedure/SurgeryThe 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)
Procedure/SurgeryThe 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)
Procedure/SurgeryThe 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
Procedure/SurgeryThe 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.
Treatment groups
180 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Paravertebral Block (PVB)Experimental treatment 2 interventions
Group B: Rhomboid Intercostal and Subserratus Plane Block (RISS)Experimental treatment 2 interventions
Group C: Pectoral Nerves Block II (PECS II)Experimental treatment 2 interventions
Group D: Intercostal Nerve Block (INB)Experimental treatment 2 interventions
Group E: Serratus Anterior Plane Block (SAPB)Experimental treatment 2 interventions
Group F: Epidural BlockExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline (before therapy),At 2hours post-surgery, At 6hours post-surgery、At 12hours post-surgery、At 24hours post-surgery.2
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.
Time frame
At baseline (in operation),At 2hours post-surgery, At 6hours post-surgery、At 12hours post-surgery、At 24hours post-surgery.Secondary outcomes
1
Patient Satisfaction Score
Patient satisfaction with postoperative analgesia will be assessed using a patient satisfaction questionnaire. The questionnaire utilizes a 10-point numerical rating scale, where 0 represents "completely dissatisfied" and 10 represents "extremely satisfied." The questionnaire will include evaluations of pain control, comfort, and trust in the medical team.
Time frame
At 24 hours post-surgery2
Postoperative Recovery Status
The Modified Postoperative Recovery Score (mPORAS) will be used to assess postoperative recovery status, including physiological recovery, pain control, mobility, and psychological state. Each item will be scored on a scale of 0 to 4, with a total score ranging from 0 to 20. Higher scores will indicate better postoperative recovery.
Time frame
Assessments will be performed at 6 hours, 12 hours, and 24 hours post-surgery, with a final assessment prior to hospital discharge.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiaguang Duan
Lead sponsor
Inner Mongolia Baogang Hospital
Sponsor institution
Source ClinicalTrials.gov
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