Menu
Recruiting NCT07390448

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks, Erector Spinae Plane Block.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

Detailed description

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

Interventions

  • Procedure Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks
    Ultrasound Guided Combined Rhomboid Intercostal Sub-serratus Plane Blocks
  • Procedure Erector Spinae Plane Block
    Erector Spinae Plane Block

Primary outcome measures

  • Total post-operative morphine consumption. [Time frame: 24 hours after the surgery]
Secondary outcome measures (4)
  • Total intra-operative fentanyl consumption [Time frame: 2-3 hours (Surgery time) surgery]
  • 1st time opioids requested post-operative. [Time frame: 24 hours after the surgery]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • National Cancer Institute - Cairo University — Cairo

Identifiers

NCT: NCT07390448 · AP2512-501-144-205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗