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

Study Overview
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Brief Summary
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Prospective interventional study

Detailed Description
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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.

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

Conditions
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Analgesia, Breast Cancer

Intervention / Treatment
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* Procedure: Erector Spinae Plane Block with Bubivacaine
* Procedure: Standard General Anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia - Exclusion Criteria: Patient refusal. Allergy or contraindication to any of the studied medications or anaesthetic agents. Chronic opioid analgesic use. Pregnancy. Morbid obesity (BMI ≥ 40 kg/m2). Scoliosis or any vertebral anomalies or previous spinal surgeries. Infection at the site of injection or any other contraindication for regional anaesthesia. Duration of surgery more than 90 minutes. Renal impairment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESPB Bubivacaine 0.25%<br>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. | Procedure: Erector Spinae Plane Block with Bubivacaine<br>* Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery<br>|
| Active Comparator: ESPB Bubivacaine 0.125%<br>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. | Procedure: Erector Spinae Plane Block with Bubivacaine<br>* Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery<br>|
| Placebo Comparator: No ESPB<br>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. | Procedure: Standard General Anaesthesia<br>* Standard General Anaesthesia without ESPB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic efficacy of ESPB | 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 | Up to 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spread of the injected dye in Erector Spinae plane | 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. | Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery. | 
| Dermatomal sensory coverage of ESPB | 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. | Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector spinae plane block, Ultrasound guided, Breast cancer surgery, Natural killer cells, Analgesia, spread