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NCT Number: NCT07390448

Rhomboid Intercostal Sub-serratus Plane Blocks and Erector Spinae Plane Block in Mastectomy Surgeries

Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.

Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.

Erector spinae plane block is a novel para-spinal regional anesthesia technique, , promises to provide effective visceral as well as somatic analgesia after carcinoma of the breast surgeries.

The ultrasound-guided rhomboid intercostal block sub-serratus plane block (RISS) is a novel analgesic technique The RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Breast cancer is the most common diagnosed malignancy among females and the 5th cause of cancer-related deaths with an estimated number of 2.3 million new cases and 685,000 deaths worldwide in 2020.

Different modalities are used for management of breast cancer including surgery, radiation therapy (RT), chemotherapy (CT), endocrine (hormone) therapy (ET), and targeted therapy. Modified Radical Mastectomy (MRM) is one of the main modalities of breast cancer treatment. It accounts for 31% of all breast surgeries. It has been reported that 40% of the females complain from moderate-to-severe pain in the immediate post-operative period after breast cancer surgery.

Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.

Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.

Erector spinae plane block is a novel para-spinal regional anesthesia technique, promises to provide effective visceral as well as somatic analgesia after carcinoma of the breast surgeries.

The ultrasound-guided rhomboid intercostal block (RIB) and rhomboid intercostal block sub-serratus plane block (RISS) are two novel analgesic techniques . Additionally, the RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Breast cancer female patients.
  • ASA class II and III.
  • Age ≥ 18 and ≤ 60 Years.
  • Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
  • Type of surgery; elective breast cancer surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection.

Exclusion criteria

  • Patient refusal.
  • Age <18 years or >65 years.
  • BMI <20 kg/m2 and >35 kg/m2.
  • Major medical conditions.
  • Pregnancy or lactation.

Treatment and study plan

Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks

Procedure

Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks

Erector Spinae Plane Block

Procedure

Erector Spinae Plane Block

Primary outcomes

  1. Total post-operative morphine consumption.

    Time frame: 24 hours after the surgery

    The total 24-hour morphine consumption will be recorded for every patient post operative.

Secondary outcomes

  1. Total intra-operative fentanyl consumption

    Time frame: 2-3 hours (Surgery time) surgery

    the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups

  2. 1st time opioids requested post-operative.

    Time frame: 24 hours after the surgery

    In case of postoperative pain recorded, rescue analgesia will be provided as IV morphine (3 mg) then continuous infusion of morphine through Patient Controlled Analgesia ( PCA ) to keep the VAS scores<3. The total 24-hour morphine consumption will be recorded for every patient.

  3. Changes and stability in Mean Arterial Blood Pressure (MAP)

    Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

    Change in Mean Arterial Blood Pressure (MAP) in mmHg

  4. Changes and stability in Heart Rate (HR)

    Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

    Change in heart rate (HR) in beat\\min

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa Elsayed Khalil Elmoghazy, MD

CONTACT

[email protected]

01009468049 ext. 0020

Ayman Sharawy Abdelrahman Aboul Nasr, MD

CONTACT

[email protected]

01282649008 ext. 0020

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

A Comparative Study Between Ultrasound Guided Combined Rhomboid Intercostal and Sub- Serratus Plane Blocks and Erector Spinae Plane Block as Perioperative Analgesia in Mastectomy Surgeries in Cancer Breast Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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