An interventional study of Erector Spinae Plane Block and Rhomboid Intercostal and Sub-Serratus block in Erector Spinae Block, Rhomboid Intercostal Sub-serratus Plane Block and Radical Mastectomy, sponsored by Bursa City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Bursa City Hospital · Not applicable, Interventional, and Treatment
Breast cancer is one of the most common malignancies and represents an important public health problem. Modified radical mastectomy (MRM) is frequently associated with acute postoperative pain resulting from a combination of somatic and neuropathic mechanisms. Inadequately controlled postoperative pain may impair recovery, delay mobilization, increase opioid consumption, and negatively affect patient satisfaction and quality of life. Therefore, effective multimodal analgesia is an important component of perioperative care in patients undergoing breast surgery.
Ultrasound-guided regional anesthesia techniques have gained increasing attention because they can provide effective postoperative analgesia while reducing opioid requirements and opioid-related adverse effects. The erector spinae plane block (ESPB) and rhomboid intercostal and subserratus plane (RISS) block are ultrasound-guided fascial plane techniques that may provide analgesia for thoracic and breast surgery.
The aim of this randomized controlled study is to compare the postoperative analgesic efficacy of ultrasound-guided ESPB and RISS block in patients undergoing modified radical mastectomy and sentinel lymph node excision. The primary objective is to compare postoperative opioid consumption between the two techniques. Secondary outcomes include postoperative pain scores, analgesic requirements, and patient satisfaction.
The hypothesis of the study is that ESPB and RISS block are comparable in terms of postoperative analgesic efficacy and that neither technique is superior to the other.
Breast cancer is one of the most common types of cancer worldwide and represents a major public health concern (1). Treatment options depend on the stage and pathological characteristics of the disease and may include radiotherapy, neoadjuvant systemic therapies, breast-conserving surgery, and mastectomy (2).
Modified radical mastectomy (MRM) is associated with significant postoperative pain, which may arise from a combination of nociceptive and neuropathic mechanisms related to surgical trauma. Inadequately controlled postoperative pain may contribute to adverse outcomes, including cardiovascular and pulmonary complications and thromboembolic events. Furthermore, acute postoperative pain may interfere with functional recovery and may contribute to the development of persistent or chronic pain, thereby negatively affecting quality of life (3). Uncontrolled postoperative pain may also prolong hospital stay, increase the risk of complications, and increase healthcare costs. Therefore, effective postoperative pain management is an important component of perioperative care in patients undergoing breast surgery (4).
Opioids remain an important component of postoperative analgesia, while nonsteroidal anti-inflammatory drugs and other non-opioid analgesics are commonly used as adjunctive therapies. However, the potential systemic adverse effects associated with these medications have increased interest in regional anesthesia techniques. Neuraxial techniques, peripheral nerve blocks, and intravenous patient-controlled analgesia can provide effective postoperative analgesia while reducing opioid requirements and facilitating postoperative recovery. In particular, ultrasound-guided regional anesthesia techniques allow real-time visualization of anatomical structures and needle advancement, potentially improving the accuracy and safety of block administration and the quality of analgesia (5).
Regional anesthesia techniques may support early postoperative mobilization and contribute to enhanced recovery after surgery (ERAS) pathways. These techniques have been reported to contribute to reducing the risk of venous thromboembolism and pulmonary complications. Improved analgesia may also facilitate deep-breathing exercises and postoperative physiotherapy. Furthermore, regional anesthesia techniques may reduce opioid and antiemetic requirements, facilitate early mobilization after mastectomy, and potentially contribute to reducing chronic postmastectomy pain (6,7).
The erector spinae muscle group extends in a craniocaudal direction on both sides of the vertebral column and lies deep to the rhomboid major muscle in the thoracic region. In an erector spinae plane block (ESPB), local anesthetic is injected into the fascial plane between the transverse process and the erector spinae muscle (8). The local anesthetic may spread in a craniocaudal direction across multiple vertebral levels. ESPB has been used for the management of acute and chronic pain and for perioperative analgesia in various thoracic and abdominal surgical procedures (8).
The analgesic effect of ESPB is thought to result from the spread of local anesthetic to the dorsal and ventral rami of the thoracic spinal nerves. However, the extent and consistency of local anesthetic spread to the ventral rami may vary (9). ESPB has also been proposed to provide an effect on both somatic and visceral pain (9). When prolonged analgesia is required, a catheter can be placed in the erector spinae plane to allow continuous or intermittent administration of local anesthetic (10). Previous studies in patients undergoing breast surgery have demonstrated that ESPB may improve postoperative pain control and reduce opioid consumption, with analgesic efficacy potentially comparable to that of paravertebral block (11,12).
The rhomboid intercostal and subserratus plane (RISS) block is an ultrasound-guided fascial plane block first described by Elsharkawy and colleagues in 2018. It has been used for the management of thoracic and upper abdominal pain (13). In this technique, local anesthetic is administered into the fascial plane between the rhomboid and intercostal muscles and subsequently into the plane superficial to the serratus anterior muscle. The technique is intended to block the lateral cutaneous branches of the intercostal nerves at approximately the T3-T9 levels (13). Medial spread of local anesthetic may also affect the dorsal rami of the thoracic spinal nerves located deep to the erector spinae muscle (13).
In the present randomized controlled study, patients scheduled to undergo modified radical mastectomy and sentinel lymph node excision will be randomized to receive either an ultrasound-guided ESPB or an ultrasound-guided RISS block as part of their perioperative analgesic management.
The primary objective of this study is to compare the postoperative analgesic efficacy of ESPB and RISS block. Postoperative opioid consumption will be evaluated as the primary outcome. Secondary outcomes will include postoperative pain intensity, rescue analgesic requirements, and patient satisfaction.
The study hypothesis is that ultrasound-guided ESPB and RISS block provide comparable postoperative analgesia in patients undergoing modified radical mastectomy and sentinel lymph node excision, and that neither technique is superior to the other in terms of postoperative analgesic efficacy.
Participants will be eligible for inclusion if they meet all of the following criteria:
Exclusion Criteria:
Participants will be excluded if they meet any of the following criteria:
Participants randomized to the ESPB group will receive an ultrasound-guided erector spinae plane block (ESPB) at the T5 vertebral level unilaterally.
Other: Erector Spinae Plane Block
Participants randomized to the RISS group will receive an ultrasound-guided rhomboid intercostal and subserratus plane (RISS) block unilaterally.
Other: Rhomboid Intercostal and Sub-Serratus block
Participants randomized to the ESPB group will receive an ultrasound-guided erector spinae plane block (ESPB) at the T5 vertebral level bilaterally. The block will be performed in the operating room after completion of surgery and before emergence from general anesthesia. Under ultrasound guidance, the erector spinae muscle and transverse process will be identified, and 30 mL of 0.25% bupivacaine will be injected into the erector spinae plane. Participants will subsequently receive standardized multimodal postoperative analgesia according to the study protocol.
Participants randomized to the RISS group will receive an ultrasound-guided rhomboid intercostal and subserratus plane (RISS) block bilaterally. The block will be performed in the operating room after completion of surgery and before emergence from general anesthesia. Under ultrasound guidance, 30 mL of 0.25% bupivacaine will be administered according to the RISS block technique. Participants will subsequently receive standardized multimodal postoperative analgesia according to the study protocol.
24-hour postoperative tramadol consumption
Total tramadol consumption during the first 24 postoperative hours will be recorded from the patient-controlled analgesia (PCA) device. The total amount of tramadol administered through the PCA device will be compared between the ESPB and RISS groups.
Time frame: From the end of surgery to 24 hours postoperatively
Postoperative static pain intensity assessed by the Numeric Rating Scale (NRS)
Postoperative pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Static NRS scores will be recorded at predefined postoperative time points and compared between the ESPB and RISS groups.
Time frame: Postoperative 0, 1, 2, 4, 6, 12, and 24 hours
Postoperative dynamic pain intensity assessed by the Numeric Rating Scale (NRS)
Postoperative pain intensity during movement will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Dynamic NRS scores will be recorded at predefined postoperative time points and compared between the ESPB and RISS groups.
Time frame: Postoperative 0, 1, 2, 4, 6, 12, and 24 hours
Patient satisfaction with postoperative pain management assessed using a Likert scale
Patient satisfaction with postoperative pain management will be assessed 24 hours after surgery using a Likert scale. Higher scores indicate greater satisfaction with postoperative pain management. Patient satisfaction scores will be compared between the ESPB and RISS groups.
Time frame: 24 hours after surgery
Incidence of opioid-related adverse effects
The incidence of opioid-related adverse effects during the first 24 postoperative hours will be recorded and compared between the ESPB and RISS groups. The evaluated adverse effects will include postoperative nausea and vomiting, pruritus, dizziness, sedation, and respiratory depression. Each adverse effect will be recorded according to predefined study criteria.
Time frame: From the end of surgery to 24 hours postoperatively
Plan to share: No — Individual participant data (IPD) will not be shared
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Bursa City Hospital