RISS vs ESP Block for Postoperative Analgesia After Mastectomy

NCT07819786 | Completed

• 1 other identifier: Bursa City Hospital Thesis
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Erector Spinae Block; Radical Mastectomy; Postoperative Analgesia; Rhomboid Intercostal Sub-serratus Plane Block

Keywords

erector spinae block; Rhomboid Intercostal Sub-serratus Plane Block; radical mastectomy; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  From the end of surgery to 24 hours postoperatively

Secondary Outcomes (4)

• Postoperative static pain intensity assessed by the Numeric Rating Scale (NRS)

  Postoperative 0, 1, 2, 4, 6, 12, and 24 hours

• Postoperative dynamic pain intensity assessed by the Numeric Rating Scale (NRS)

  Postoperative 0, 1, 2, 4, 6, 12, and 24 hours

• Patient satisfaction with postoperative pain management assessed using a Likert scale

  24 hours after surgery

• Incidence of opioid-related adverse effects

  From the end of surgery to 24 hours postoperatively

Study Arms (2)

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.

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.

Other: Rhomboid Intercostal and Sub-Serratus block

Interventions

Erector Spinae Plane Block OTHER

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.

ESPB(erector spinae plane block)

Rhomboid Intercostal and Sub-Serratus block OTHER

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.

RISSb(rhomboid intercostal subserratus plane block)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bursa City Hospital: lead
• Ahmet Kaciroglu: collaborator

Study Sites (1)

Bursa City Hospital

Bursa, nilüfer, 16010, Turkey (Türkiye)

Location

Related Publications (1)

• 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

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: January 1, 2026
• Primary Completion: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)