Erector Spinae BlockNCT07819786
RISS vs ESP Block for Postoperative Analgesia After Mastectomy
A study testing Erector Spinae Plane Block and Rhomboid Intercostal and Sub-Serratus block in people with Erector Spinae Block and Rhomboid Intercostal Sub-serratus Plane Block, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Erector Spinae Block, Rhomboid Intercostal Sub-serratus Plane Block, Radical Mastectomy
- What is being tested?
- Erector Spinae Plane Block and Rhomboid Intercostal and Sub-Serratus block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be eligible for inclusion if they meet all of the following criteria:
- Age between 18 and 80 years.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Scheduled for elective modified radical mastectomy.
- Willingness to participate in the study and ability to provide written informed consent.
Who cannot join
- Participants will be excluded if they meet any of the following criteria:
- Refusal to participate in the study or inability to provide informed consent.
- Known or suspected allergy to local anesthetic agents.
- Coagulopathy or a contraindication to regional anesthesia.
- Requirement for uninterrupted anticoagulant therapy.
- Infection at the site of block injection.
- Any other condition considered by the investigators to make participation in the study inappropriate or unsafe.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Postoperative Analgesic Efficacy of Ultrasound-Guided Rhomboid Intercostal and Subserratus Plane Block Versus Erector Spinae Plane Block in Modified Radical Mastectomy Surgery
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Erector Spinae Block, Rhomboid Intercostal Sub-serratus Plane Block, Radical Mastectomy, Postoperative Analgesia
- Being tested
- Erector Spinae Plane Block, Rhomboid Intercostal and Sub-Serratus block
- Keywords
- erector spinae block, Rhomboid Intercostal Sub-serratus Plane Block, radical mastectomy, Postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockOther
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.
Rhomboid Intercostal and Sub-Serratus blockOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ESPB(erector spinae plane block) | Experimental | Participants randomized to the ESPB group will receive an ultrasound-guided erector spinae plane block (ESPB) at the T5 vertebral level unilaterally. Receives: Other: Erector Spinae Plane Block |
| RISSb(rhomboid intercostal subserratus plane block) | Experimental | Participants randomized to the RISS group will receive an ultrasound-guided rhomboid intercostal and subserratus plane (RISS) block unilaterally. Receives: Other: Rhomboid Intercostal and Sub-Serratus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the end of surgery to 24 hours postoperatively
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the end of surgery to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Jan 2026
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Collaborators
- Ahmet Kaciroglu
- Responsible party
- Principal investigator, eralp çevikkalp, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819786
- Sponsor's protocol ID
- Bursa City Hospital Thesis
- Status last verified
- Dec 2025
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Publications
1.Ç. Erhan, "Meme Kanseri Tedavileri ve Tiroid Fonksiyonları Üzerine Etkileri," 2026, pp. 487-493. doi: 10.37609/akya.3852.c2823. 2.M. Liu, C. Wang, F. Xie, P. Yuan, and S. Wang, "Clinical practice guidelines for diagnosis and treatment of invasive breast cancer: Chinese Society of Breast Surgery (CSBrS) practice guidelines 2021," Chinese Medical Journal , vol. 134, no. 9, pp. 1009-1013, Apr. 2021, doi: 10.1097/cm9.0000000000001498. 3.C. Kubulus et al., "Does the quality of pain relief after major surgery influence the risk of postoperative complications? A prospective observational study," PLoS ONE, vol. 20, no. 9, Sep. 2025, doi: 10.1371/journal.pone.0332866. 4.A. Günay and A. Karahan, "Mastektomi ile Eş Zamanlı Meme Rekonstrüksiyonu Uygulanan Hastalarda Dijital Teknoloji Destekli Eğitim ve İzlemin Anksiyete, Ağrı, Uyku ve Yaşam Kalitesi Üzerine Etkisi: Randomize Kontrollü Çalışma Protokolü," Aug. 2024, Accessed: Jun. 2026. [Online]. Available: https://dergipark.org.tr/tr/pub/busbid/issue/89033/1541211 5.M. Şimşek, "Regional Anestezi İlkeleri ve Uygulamaları," 2025, pp. 39-54. doi: 10.37609/akya.3854.c1286. 6.P. Kumar, S. Yadav, and R. Agarwal, "Enhanced Recovery After Surgery (ERAS): Role of the Anesthesiologist," International Journal of Current Pharmaceutical Review and Research, vol. 18, no. 2, Feb. 2026, doi: 10.25258/ijcpr.18.2.132. 7.R. Abid et al., "Postoperative Pain Control Using Regional Nerve Blocks in Breast Cancer Surgery Mastectomy," Journal of Health Wellness and Community Research, Jun. 2025, doi: 10.61919/hdnm5b63. 8.S. Du, Q. Xie, T. Liang, and Y. Feng, "The Application of Erector Spinae Plane Block in Chronic Pain Management: From Anatomical Mechanisms to Clinical Innovations," Journal of Pain Research, pp. 7139-7148, Dec. 2025, doi: 10.2147/jpr.s548853. 9.A. Clairoux et al., "Erector spinae plane block did not improve postoperative pain-related outcomes and recovery after video-assisted thoracoscopic surgery : a randomised cont
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Efficacy of Ultrasound-Guided Rhomboid Intercostal and Subserratus Plane Block Versus Erector Spinae Plane Block in Modified Radical Mastectomy Surgery
- ClinicalTrials.gov ID
- NCT07819786
- Acronym / sponsor ID
- Bursa City Hospital Thesis
- Conditions
- Erector Spinae Block, Rhomboid Intercostal Sub-serratus Plane Block, Radical Mastectomy, Postoperative Analgesia
- Keywords
- erector spinae block, Rhomboid Intercostal Sub-serratus Plane Block, radical mastectomy, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Collaborators
- Ahmet Kaciroglu
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB(erector spinae plane block) | Experimental | Other: Erector Spinae Plane BlockParticipants randomized to the ESPB group will receive an ultrasound-guided erector spinae plane block (ESPB) at the T5 vertebral level unilaterally. |
| RISSb(rhomboid intercostal subserratus plane block) | Experimental | Other: Rhomboid Intercostal and Sub-Serratus blockParticipants randomized to the RISS group will receive an ultrasound-guided rhomboid intercostal and subserratus plane (RISS) block unilaterally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Scheduled for elective modified radical mastectomy.
- Willingness to participate in the study and ability to provide written informed consent.
Key exclusion criteria (7 listed)
- Refusal to participate in the study or inability to provide informed consent.
- Known or suspected allergy to local anesthetic agents.
- Coagulopathy or a contraindication to regional anesthesia.
- Requirement for uninterrupted anticoagulant therapy.
- Infection at the site of block injection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockParticipants 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. | Other | ESPB(erector spinae plane block) |
| Rhomboid Intercostal and Sub-Serratus blockParticipants 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. | Other | RISSb(rhomboid intercostal subserratus plane block) |
Primary outcome
24-hour postoperative tramadol consumption
Time frame: From the end of surgery to 24 hours postoperatively
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.
4 secondary outcomes
Postoperative static pain intensity assessed by the Numeric Rating Scale (NRS)
Time frame: Postoperative 0, 1, 2, 4, 6, 12, and 24 hours
Postoperative dynamic pain intensity assessed by the Numeric Rating Scale (NRS)
Time frame: Postoperative 0, 1, 2, 4, 6, 12, and 24 hours
Patient satisfaction with postoperative pain management assessed using a Likert scale
Time frame: 24 hours after surgery
Incidence of opioid-related adverse effects
Time frame: From the end of surgery to 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background1.Ç. Erhan, "Meme Kanseri Tedavileri ve Tiroid Fonksiyonları Üzerine Etkileri," 2026, pp. 487-493. doi: 10.37609/akya.3852.c2823. 2.M. Liu, C. Wang, F. Xie, P. Yuan, and S. Wang, "Clinical practice guidelines for diagnosis and treatment of invasive breast cancer: Chinese Society of Breast Surgery (CSBrS) practice guidelines 2021," Chinese Medical Journal , vol. 134, no. 9, pp. 1009-1013, Apr. 2021, doi: 10.1097/cm9.0000000000001498. 3.C. Kubulus et al., "Does the quality of pain relief after major surgery influence the risk of postoperative complications? A prospective observational study," PLoS ONE, vol. 20, no. 9, Sep. 2025, doi: 10.1371/journal.pone.0332866. 4.A. Günay and A. Karahan, "Mastektomi ile Eş Zamanlı Meme Rekonstrüksiyonu Uygulanan Hastalarda Dijital Teknoloji Destekli Eğitim ve İzlemin Anksiyete, Ağrı, Uyku ve Yaşam Kalitesi Üzerine Etkisi: Randomize Kontrollü Çalışma Protokolü," Aug. 2024, Accessed: Jun. 2026. [Online]. Available: https://dergipark.org.tr/tr/pub/busbid/issue/89033/1541211 5.M. Şimşek, "Regional Anestezi İlkeleri ve Uygulamaları," 2025, pp. 39-54. doi: 10.37609/akya.3854.c1286. 6.P. Kumar, S. Yadav, and R. Agarwal, "Enhanced Recovery After Surgery (ERAS): Role of the Anesthesiologist," International Journal of Current Pharmaceutical Review and Research, vol. 18, no. 2, Feb. 2026, doi: 10.25258/ijcpr.18.2.132. 7.R. Abid et al., "Postoperative Pain Control Using Regional Nerve Blocks in Breast Cancer Surgery Mastectomy," Journal of Health Wellness and Community Research, Jun. 2025, doi: 10.61919/hdnm5b63. 8.S. Du, Q. Xie, T. Liang, and Y. Feng, "The Application of Erector Spinae Plane Block in Chronic Pain Management: From Anatomical Mechanisms to Clinical Innovations," Journal of Pain Research, pp. 7139-7148, Dec. 2025, doi: 10.2147/jpr.s548853. 9.A. Clairoux et al., "Erector spinae plane block did not improve postoperative pain-related outcomes and recovery after video-assisted thoracoscopic surgery : a randomised cont
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Rhomboid Intercostal and Sub-Serratus block in people with Erector Spinae Block and Rhomboid Intercostal Sub-serratus Plane Block, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour postoperative tramadol consumption (time frame: From the end of surgery to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07819786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.