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

Alexandria University60 enrolled

Overview

Prospective interventional study

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Analgesia Breast Cancer

Interventions

Erector Spinae Plane Block with BubivacainePROCEDURE

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

Standard General AnaesthesiaPROCEDURE

Standard General Anaesthesia without ESPB

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria:ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia \- Exclusion Criteria: 1. Patient refusal. 2. Allergy or contraindication to any of the studied medications or anaesthetic agents. 3. Chronic opioid analgesic use. 4. Pregnancy. 5. Morbid obesity (BMI ≥ 40 kg/m2). 6. Scoliosis or any vertebral anomalies or previous spinal surgeries. 7. Infection at the site of injection or any other contraindication for regional anaesthesia. 8. Duration of surgery more than 90 minutes. 9. Renal impairment.

Locations (1)

Medical Research Institute, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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

Time frame: Up to 24 postoperative hours

Secondary Outcomes

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.

Time frame: 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.

Time frame: Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB.

Data from ClinicalTrials.gov

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