Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy
Condition: Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to compare and evaluate the analgesic effects of ultrasound-guided
      Erector Spinae Plane block using low volumes and high concentrations versus high volumes and
      low concentrations in patients undergoing MRM.
    

Detailed description: 
      Multiple regional techniques have been developed in recent years for postoperative analgesia
      of breast surgery including ESPB aiming to be effective and associated with less
      complications when compared to the gold standard techniques (thoracic epidural analgesia or
      paravertebral block)..

      Ultrasound guided erector spinae plane (ESPB) block was described in 2016 as a novel regional
      anesthetic technique for acute and chronic thoracic pain, it has been used as a regional
      anesthetic technique for breast surgery based on case reports and case series. It is a
      paraspinal fascial plane block that involves injection of local anesthetic deep in the
      erector spinae muscle and superficial to the tips of the thoracic transverse processes. The
      site of injection is distant from the pleura, major blood vessels, and spinal cord; hence,
      performing the ESPB has relatively few contraindications. The injected local anesthetic drug
      blocks the ventral and dorsal rami of spinal nerves on the paravertebral area .

      Multiple studies have reported improved efficiency of interfascial blocks by increasing the
      volume of injection promoting better spread of local anesthesia. According to the authors
      best knowledge there is no studies comparing different volumes and concentration in ESPB in
      patients undergoing MRM This study aims to see the effect of fixing the drug mass of
      anaesthetic given in both groups, while altering the concentration of the anesthetic and
      total volume administered. One group will receive a lower concentration and higher volume,
      while the other will receive a higher concentration and lower volume.
    

Intervention name(s): Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block); Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)
Intervention type(s): Drug; Drug
Intervention description(s): Patients will preoperatively receive low concentration-high volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room ) one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline} for each patient; Patients will preoperatively receive high concentration-low volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room (one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% } for each patien).
Other intervention name(s): Erector Spinae Plane Block with high volume-low concentration bupivacaine 0.25%; Erector Spinae Plane Block with low volume-high concentration bupivacaine 0.25%
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We hypothesize that high volume low concentration ultrasound-guided Erector Spinae Plane block is going to be more effective than low volume high concentration in patients undergoing MRM. Many authors advocate increasing the volume of injection in fascial plane blocks to allow better spread of local anesthetic according to multiple studies
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care