Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block
Condition: Breast Cancer Surgery; Postoperative Analgesia
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer surgery is one of the most common surgeries, due to the high incidence of
      breast cancer. Unfortunately, patients experience significant postoperative acute pain,
      placing them at risk for increased clinical morbidity and the development of disabling
      chronic pain which may rich up to 55% . The intensity of perioperative pain experienced by
      the patient is one of the best predictors of chronic pain.

      However, postoperative analgesia in breast cancer surgery is difficult due to the extensive
      nature of the surgery and the complex innervation of the breast.

      Several newly described regional anesthesia techniques exist to control perioperative pain,
      including the Paravertebral block (PVB) which has been proved to be the most effective one.
      The anatomic proximity of the pleura and central neuraxial system makes it a particularly
      challenging technique and carrying a risk of pneumothorax.

      The Erector Spinae Plane Block (ESPB) is a novel interfascial plane block described by Forero
      et al in September 2016. Local anesthetic injection is performed beneath the erector spinae
      muscle. Local anesthetic (LA) expected to achieve paravertebral spread of three vertebral
      levels cranially and four levels caudally, blocking the dorsal and ventral rami of the spinal
      nerves.The easy, fast and safe execution of ESPB makes it a promising technique in the
      context of surgical pain during breast cancer surgery.

      There is no sufficient randomized controlled trials that assess the effectiveness of ESPB in
      controlling post-operative breast surgery pain.

      The main purpose of this study is to evaluate the postoperative analgesic effect of
      Ultrasound-guided ESPB in patients undergoing breast cancer surgery.
    

Detailed description: 
      It is a prospective double blind trial. Sixty female patient aged between 20-65 years old
      with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for
      elective surgery for breast cancer were included in the study. Only unilateral surgical
      procedures will be included. The patients will be randomized into two groups:

      Group B (ESP block): Patients in the experimental arm will receive an ESPB prior to induction
      of general anesthetic.

      Group P: (sham ESP block): Patients allocated to the placebo-control arm will receive a
      placebo injection of normal saline in almost identical fashion to that of the ESP block.

      Intravenous access will be obtained with an 18-gauge intravenous (IV) cannula in the
      contralateral upper limb of the surgical site and monitors (pulse oximeter,
      electrocardiography, non-invasive blood pressure (NIBP) will be applied.

      All blocks will be performed before induction of general anesthesia.

      ESPB technique:

      The ESPB will be done in the sitting position using linear ultrasound probe (L10) of MySonoU6
      machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane
      approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal
      approach. Three muscles will be identified superficial to the transverse process shadow as
      follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected
      between the erector spinae muscle and transverse process. Following confirmation of the
      correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40
      mL of fluid will be injected next. The distribution will be observed in both cranial and
      caudal directions.

        -  Group B (ESP block) will receive 150 mg of Ropivacaine : 40cc of Ropivacaine
           (3.75mg/cc).

        -  Group P (Sham ESP block) will receive 40 cc of normal saline.

      General Anesthesia:

      All patients will receive pre-oxygenation with 100% O2 for 3 min. Anesthesia will be induced
      by using fentanyl 2μg/kg, Propofol 2-3 mg/kg and Atracurium 0.5 mg/kg. During anesthesia
      maintenance, monitoring will include Pulse Oximetry, an Electrocardiogram, Non-Invasive Blood
      Pressure (NIBP), end-tidal Carbon Dioxide, End-Tidal Sevoflurane, and Fraction of Inspired
      Oxygen.

      The reinjection of 0.5μg/kg of fentanyl will be given intraoperatively either when heart rate
      or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal
      records.

      Paracetamol 1 g IV and Ketoprofen 100 mg intramuscular (IM) will be administered for
      postoperative analgesia at the end of surgery. Anesthesia will be discontinued and tracheal
      extubation will be done once patient fulfilled the extubation criteria. In the recovery room,
      all patients will be given a patient-controlled analgesia device (PCA) containing morphine 1
      mg/ml-1 ,set to deliver a 1 mg bolus dose of morphine, with an 5 min lockout time and 12mg 1
      h limit. Postoperative pain will be assessed using a visual analogue scales (VAS) scores
      ranging from zero (no pain) to 10 (worst imaginable pain). The VAS scores will be recorded at
      1,2,4,8 6, 12, 16, 20 and 24 h postoperatively.If VAS scores are superior to 6 the
      investigators will resort to rescue analgesia as following: If 6<VAS<8: paracetamol 1g IV
      will be administered and if VAS>8: paracetamol 1g IV associated to ketoprofen100mg IM.

      Incidence of nausea and vomiting, and total morphine consumption during the 24-h
      postoperative period will be recorded.
    

Intervention name(s): erector spinae plane block; sham erector spinae plane block
Intervention type(s): Procedure; Procedure
Intervention description(s): The ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected between the erector spinae muscle and transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid. Then 40cc of Ropivacaine (3.75mg/cc) will be injected .The distribution will be observed in both cranial and caudal directions.; The sham ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40 mL of fluid will be injected next between the erector spinae muscle and transverse process. Then 40cc of normal saline will be injected.The distribution will be observed in both cranial and caudal directions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: opioid consumption; erector spinae plane block; breast surgery; analgesia; PCA morphine; Locoregional anesthesia; breast cancer surgery