Rhomboid Intercostal and Subserratus Plane Block
Condition: Postoperative Pain; Regional Anesthesia Morbidity
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This clinical trial will be conducted at Tanta University Hospitals, General Surgery
      Hospitals on female patients undergoing radical mastectomy

      . All the patients will receive general anesthesia.

      The patients will be randomly allocated into one of the following two groups;- - Control
      group (30 patients): The patients in this group will receive sham rhomboid intercostal and
      subserratus plane.

      - Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this
      group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.

      The primary outcome measure will be the total dose of morphine consumed in the first 24 h
      after surgery and the secondary outcome will be the postoperative pain score.
    

Detailed description: 
      This prospective randomized controlled study will be carried out on female patients who will
      be presented for radical mastectomy in the general surgery department in Tanta university
      hospitals over three month duration and 6 months follow up that starts immediately after
      obtaining ethical committee approval, an informed written consent will be obtained from all
      the participants, all patients data will be confidential and will be used for the current
      study only.

      Any unexpected risks that will appear during the research will be announced to the
      participants and to the ethical committee at time and adequate measures will be taken to
      resolve and avoid these risks.

      Expected risks to the patients: patients enrolled in this study will minimal risk of local
      hematoma that which will be managed by adequate compression and minimal risk of infection
      that will be guarded against by adequate sterilization and prophylactic antibiotic.

      There will be adequate supervision to maintain the privacy of patients and confidentiality of
      data.

      There will be no conflict of interest, nor conflict with religion, law, or society standards.

      The research will be beneficial to the society and has no risk of environmental pollution.

      Upon arrival of the patient to the operating room, intravascular access will be established,
      fluid preload will be started, and basic monitor will be attached. After positioning and
      adequate sterilization of the back. The patients will be randomly allocated into two equal
      groups by the aid of computer-generated software of randomization; - • Control group (30
      patients): The patients in this group will receive sham rhomboid intercostal and subserratus
      plane.

      • Rhomboid intercostal and subserratus plane block group (30 patients): The patients in this
      group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.

      Anesthesia will be induced by fentanyl 1 ug/kg, propofol 1.5 mg/kg, and cis-atracurium 0.15
      mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be
      connected to a mechanical ventilator with its parameters adjusted to maintain etCo2 32-36
      mmhg. Anesthesia will be maintained by isoflurane 1% MAC in mixture of oxygen:air 1:1 with
      the use of low flow (1 ml/min).

      All the patients will be connected to a bispectral index monitor with maintaining its value
      ranging 40-60. Increase in the BIS value over 60 will be managed by additional dose of
      fentanyl 1ug/kg till decrease the BIS below 60. If the BIS is still over 60, increasing the
      isoflurane 0.2 % MAC till it decreased below 60.

      At the end of the surgery, switching off the inhalational anesthetics, reversal of muscle
      relaxation, and awake tracheal extubation will be done with transporting the patients to the
      PACU for postoperative follow up and monitoring.
    

Intervention name(s): Control group; Rhomboid intercostal and subserratus plane block group
Intervention type(s): Procedure; Procedure
Intervention description(s): The patients in this group will receive sham rhomboid intercostal and subserratus plane.; The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
Other intervention name(s): Sham block group; Experimental group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Radical Mastectomy; Postoperative pain; Morphine consumption; subserratus plane block