Effect of Ultrasound Guided L1,L2 Paravertebral Block in Decrease the Requirements for Hypotensive Drugs During General Anesthesia in Patients Undergoing Hip Surgeries.
Condition: Ultrasound Guided L1,L2 Paravertebral Block
Study type: Interventional

Summary: 
      The paravertebral block (PVB) is a block of the mixed nerve soon after it exits the
      intervertebral foramen.(2) It provides intense unilateral analgesia of long duration and has
      become the primary anesthetic for many applications.(3) Paravertebral Block (PVB) involves
      injection of local anaesthetic in a space immediately lateral to where the spinal nerves
      emerge from the intervertebral foramina. This technique is being used increasingly for not
      only intra-operative and post-operative analgesia but also as a sole anaesthetic technique
      for carrying out various procedures. This popularity is mainly due to the ease of the
      technique and fewer complications.(4) The increasing demand for hip arthroplasties over the
      last decades has sparked the creation of new and innovative anesthetic techniques and
      analgesic pathways with the goal to support best possible outcomes among this frequently
      elderly patient population. As a result, today different perioperative treatment pathways are
      available to physicians and their patients. In this context, the focus has shifted to
      techniques based on regional anesthetic and analgesic techniques. This trajectory has been
      fueled by a number of advantages including effective, long-lasting and focused pain control,
      decreased need for systemic analgesics and earlier mobilization.
    

Detailed description: 
      Paravertebral block group: The patient will be reviewed then moved to the block area.
      Intravenous access, commencement of IV crystalloid, and standard patient monitoring with ECG
      , NIBP , pulse oximetry Sedation 2 mg midazolam and oxygen will be commenced prior to
      insertion of the block.

      The equipments area 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle), Skin antiseptic
      solution, Sterile gloves, marking pen, 1-2 ml of 1% lignocaine for skin infiltration and 20
      ml of 0.25% Bupivacain.

      The patient will be positioned in lateral decubitus position with the side to be blocked
      upward and supported by an attendant. The back should assume kyphosis.

      The following boney surface anatomy landmarks are helpful to identify spinal levels and to
      estimate the position of the transverse processes: Iliac crest (corresponds to L3-4 or L2-3),
      Spinous processes (midline) , Tips of scapulae (corresponds to T7), Midline and 2.5 cm
      lateral to the midline.

      The level between L1 and L2 will be identified using ultrasound as well as transverse
      processes depth. Insertion points will be marked 2.5 cm lateral to the superior aspect of
      corresponding spinous processes, A skin wheal will be made using lidocaine 1% at each level
      and then a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced until it
      made contact with the transverse process. The needle will be withdrawn slightly and walked
      off caudally to an additional depth of 1 cm. Once this is reached, 20cc of bupivacaine 0.25
      %( 10ml for each level) will be injected slowly after negative aspiration was confirmed at
      each level.

      An 8-14 MHz curved array probe (Siemens ACUSON X300 Ultrasound System) was applied
      longitudinally to the paravertebral area.

      An 18G Tuohy needle was inserted perpendicularly at L1,2 to hit the transverse process via an
      out-of-plane approach. This was then directed over the top of the bony structure. The
      deviation of the needle from the perpendicular line was kept at 15°. The paravertebral space
      was identified using loss of resistance to normal saline injection without ultrasound. After
      negative aspiration, Transverse process visualisation was possible. Distances measured using
      ultrasound correlated well with needle depth. Injection of local anaesthetic was visualised
      as turbulence at L1,2 in all patients. Ultrasound imaging not only helped determine needle
      insertion sites, but also provides information on the depth to the paravertebral space.

      The onset time for this block is 15-25 min. The first sign of the blockade is the loss of
      pin-prick sensation at the dermatomal distribution of the L1 and L2 roots.

      After finishing the block the patient will be moved to the operation room.

      All patients in the study will receive general anesthesia in the form of propofol 2mg/kg ,
      atracurium0.5ml/kg ,fentanyl 100 microgram in induction with ETT and mechanical ventilation ,
      full monitoring with ECG , NIBP , puls oximetry will be applied.

      To control intraoperative blood pressure, fentanyl will be used as well as, hypotensive drugs
      ( propranolol and nitroglycerineand the total dose will be recorded.

      To achieve post operative analgesia, intravenous paracetamol( 1gram ) and pethidine IV (50 mg
      ) will be added when needed.

      All the doses of the drugs intraoperative and postoperative will be collected.

      After completion of surgical procedure and emergence from anesthesia the patient will be
      referred to the recovery then will be discharged to ward unit by request of surgeon for close
      observation.

      Hemodynamics will be recorded; requirements for opioids and hypotensive drugs will be
      recorded and observing postoperative pain and postoperative analgesic requirements.

      Pain assessment by the aid of Visual analogue scale (VAS), which is consisted of a "10 cm"
      line with one end labeled no pain and other end labeled worst intolerable pain. The patients
      marked the line at the point that best describing the pain intensity. The preoperative
      assessment included training of the patients about (VAS) for postoperative pain. The length
      of the line to the patient's mark will be measured and recorded postoperative after 30 min.,
      2,4, 6, 8,12 and 24 hours.
    

Intervention name(s): Ultrasound guided PVB with General Aneasthesia; Ultrasound; Paravertebral block; General Aneasthesia
Intervention type(s): Procedure; Device; Drug; Drug
Intervention description(s): An 18G Tuohy needle was inserted perpendicularly at L1,2 to hit the transverse process via an out-of-plane approach. This then directed over the top of the bony structure. The deviation of the needle was kept at 15°. The space was identified using loss of resistance without U/S After negative aspiration, Transverse process visualisation was possible. Distances measured using U/S correlated well with needle depth. Injection of local anaesthetic was visualised as turbulence at L1,2 in all patients. The onset time for this block is 15-25 min; Ultrasound; Patients will receive single shot L1-L2 PVB before undergoing GA; General Aneasthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: after approval of the ethical committee (N-73-2017)Which approval date was 12/2/2018 74 patients scheduled for elective hip surgery were included in the study after detailed description and signing a detailed informative consent (figure1). The patients were randomized to two groups using a computer-generated list and kept in a sealed envelope into two groups:
Group P: 37 patients were received single shot L1-L2 paravertebral block before undergoing general anesthesia (GA).
Group G: 37 patients were received GA. The target of the mean blood pressure was to be more than 50mm Hg while the systolic pressure to be between 80 and 100 mm Hg and the diastolic blood pressure targeted to be 50 to 70 mmHg.
Masking: Double (Care Provider, Investigator)
Primary purpose: Supportive Care