Clinical trial · Interventional
Regional Anesthesia Techniques in Breast Surgery
Regional Anesthesia Techniques in Breast Surgery: a Comparative Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Augmentation | — | UNRESOLVED | — |
| Fibroadenoma | Breast Fibroadenoma | ALIAS | 0.90 |
| Mastectomy | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epidural Block | Procedure | — | UNRESOLVED |
| General Anesthesia (GA) | Device | — | UNRESOLVED |
| Intercostal Nerve Block (INB) | Procedure | — | UNRESOLVED |
| Paravertebral Block (PVB) | Procedure | — | UNRESOLVED |
| Pectoral Nerves Block II (PECS II) | Procedure | — | UNRESOLVED |
| Rhomboid Intercostal and Subserratus Plane Block (RISS) | Procedure | — | UNRESOLVED |
| Serratus Anterior Plane Block (SAPB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Paravertebral Block (PVB)
- description
- 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.
- interventionNames
- Device: General Anesthesia (GA)
- Procedure: Paravertebral Block (PVB)
- type
- EXPERIMENTAL
- label
- Rhomboid Intercostal and Subserratus Plane Block (RISS)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Known allergy to local anesthetics. * Pregnancy or lactation. * Coagulation disorders. * Severe cardiopulmonary disease. * Local infection at the injection site. * Unstable psychiatric illness.
References
Publications (0)
Data not yet available