Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Bupivacaine

Morphine

20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 20 ml bupivacaine 0.25 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4.

20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 40 ml bupivacaine 0.125 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4.

20 patients will undergo standard general anaesthesia as a control group and postoperative analgesia with intravenous morphine patient controlled analgesia (PCA) and rescue analgesia if required.

Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery

Erector Spinae Plane Block with Bubivacaine

Standard General Anaesthesia without ESPB

Standard General Anaesthesia

Emad Eldin Abd El Monem Arida, Professor

The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery.

The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB.

The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery.

Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.

US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation

Ultrasound Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation

All IPD that underlie results in a publication

Immunomodulation of ESPB by measuring Natural Killer cells cytotoxicity. Samples of 1 ml of patients' peripheral blood will be collected on EDTA for flow cytometry to enumerate for both cytotoxic lymphocyte populations (NK cells and cytotoxic t lymphocytes (Ctls)). CD 56 will be used as a marker for NK cells, while CD 8 will be used as a marker for Ctls.

Cytotoxicity assay will be done by measuring the release of lactate dehydrogenase (LDH) from cells. Then ratio of LDH released specifically from NK cells will be correlated according to the results of flow cytometry.

Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain

5 ml of radio-contrast dye will be injected in Erector Spinae plane with different dose of Bupivacaine at the level of 4th thoracic vertebra then spread of the dye will be assessed by CT scan (for example dye spread to first thoracic vertebra level cranially and 9th thoracic vertebra caudally).

3 D reconstruction of the image will be done then Craniocaudal spread of the contrast and spread to Paravertebral space, epidural space or rami of the spinal nerves will be assessed and recorded.

will be assessed by hyposthesia to cold sensation. Field of sensory block from T1 to T6 will be assessed bilaterally every 3 minutes for 15 minutes after deep ESPB using a piece of cotton soaked in iced water. The adequacy of sensory block T1-T6 will be determined before induction of general anaesthesia.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation	NCT04796363	Analgesia Breast Cancer	Erector Spinae ... Standard Genera...	20 Years - 50 Years	Alexandria University
US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation	NCT04796363	Analgesia Breast Cancer	Erector Spinae ... Standard Genera...	20 Years - 50 Years	Alexandria University

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