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Completed

NCT Number: NCT04796363

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

Prospective interventional study

Completed

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Key information

Conditions

Analgesia Agnosia Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Research Institute, Alexandria University

Alexandria, 21561, Egypt

About this 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Erector Spinae Plane Block with Bubivacaine

Procedure

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

Standard General Anaesthesia

Procedure

Standard General Anaesthesia without ESPB

Primary outcomes

  1. Analgesic efficacy of ESPB

    Time frame: Up to 24 postoperative hours

    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

Secondary outcomes

  1. Spread of the injected dye in Erector Spinae plane

    Time frame: Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery.

    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.

  2. Dermatomal sensory coverage of ESPB

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

Other outcomes

  1. Immunomodulation of ESPB

    Time frame: Before ESPB and 24 hours after the block.

    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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 12, 2021
Registry last updated
Apr 11, 2022

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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