Retrolaminar Thoracic Paravertebral Block
Condition: Regional Anesthesia Morbidity; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This clinical study will be conducted on female patients admitted to The General Surgery
      Department of Tanta Faculty of Medicine for a period of 9 months.

      Patients will be randomly allocated into one of the following two groups;- • Ordinary
      approach group (30 patients): The patients in this group will receive ordinary
      ultrasound-guided thoracic paravertebral block.

      • Retro-laminar approach group (30 patients): The patients in this group will be receive real
      ultrasound-guided Retrolaminar thoracic paravertebral block.

      All the patients will receive general anesthesia with attachment to a monitor (5 ASA
      Monitoring) In addition to bispectral index.
    

Detailed description: 
      This prospective randomized controlled study will be carried out on female patients who will
      be presented for breast surgery in the General Surgery Department in Tanta university
      hospitals over 3 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 have a very minimal risk
      of pleural puncture that will be managed by adequate observation and chest tube insertion
      whenever indicated. They may have a minimal risk of hypotension that will be managed by
      intravenous fluids and intravenous ephedrine 10 mg.

      There will be adequate supervision to maintain the privacy of patients and confidentiality of
      data that will be used in the current study only.

      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.

      Once the patients will arrive 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; - •
      Ordinary approach group (30 patients): The patients in this group will receive ordinary
      ultrasound-guided thoracic paravertebral block.

      • Retro-laminar approach group (30 patients): The patients in this group will be receive real
      ultrasound-guided Retrolaminar thoracic paravertebral block.

      Anesthesia will be induced by fentanyl 1.5 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 34-38
      mmhg. Anesthesia will be maintained by isoflurane 1.5% 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): Ordinary approach paravertebral block; Retrolaminar paravertebral block
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound guided thoracic paravertebral block. At the appropriate dermatome, the needle (22-gauge, 8-10-cm, short bevelled spinal needle, or a Touhy needle if a catheter is to be placed) is inserted 2.5-3 cm lateral to the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process at a variable depth (2-4 cm) depending on the build of the individual. The needle is then walked above the transverse process and gradually advanced until a loss of resistance to air or saline, or a subtle 'click' is felt as the superior costotransverse ligament is penetrated, usually within 1-1.5 cm from the superior edge of the transverse process.; In the retrolaminar approach to TPVB or retrolaminar block (RB), local anesthetic (LA) is injected into the retrolaminar plane to achieve a truncal sensory block like that of traditional TPVB. It has been postulated that during RB, LA spreads from the injection plane to the thoracic paravertebral space (TPVS) through the superior costotransverse ligament (SCTL). Retrolaminar block will be performed under ultrasound guidance, as a single injection.
Other intervention name(s): thoracic paravvertebral blovk; Thoracic retrolaminar paravertebral block
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Retrolaminar; Paravertebral; Breast surgery; Postoperative pain