As of October 2019, when the investigators received the approval of the ethics committee,
      patients who were decided to undergo kyphoplasty with vertebral compression fracture will be
      included in the study. The patients will be divided into three groups according to the
      anesthetic method as conventional local anesthesia infiltration (CLIA) method and
      extrapedicular infiltration anesthesia (EPIAA) and 30 other patients as US guided erector
      spina group (ESP) for a total of 60 patients. The degree of pain in the intraoperative period
      will be assessed using a numerical rating scale. Patients with severe pain (NRS> 4) will
      receive 50 micrograms of fentanyl as an additional analgesic. Sedation levels of the patients
      will be evaluated with ramsey sedation scale (1-6). Patients with a sedation score of 1 will
      receive 2 mg of midazolam. During the procedure, pain scores at 0 minutes, 15, 30 and 45
      minutes, sedation scores, additional analgesic and sedation amounts administered, and
      hemodynamic parameters will be recorded. The statistical difference between the groups will
      be compared

Effectiveness of Erector Spinae Block in Kyphoplasty

Spinal Fractures

Anesthesia, Regional

Anesthetics, Local

Analgesia

After the approval of the Ethics Committee in October 2019, kyphoplasty patients with
      vertebral compression fractures will be included in the study. Before the procedure,
      necessary information will be given to the patients and all of the patients will have their
      consent to work. Patients will be randomized into three groups. According to the anesthetic
      method, 30 patients will be classified as conventional local anesthesia infiltration (CLIA)
      method and 30 patients will be classified as extrapedicular infiltration anesthesia (EPIAA)
      and 30 others will be classified as US guided erector spina group (ESP). All patients will
      receive 2 mg midazolam before sedation. In all groups, the pedicle will be determined as the
      first step and 5 mL of 1% Lidocaine Hydrochloride will be applied bilaterally to the skin,
      subcutaneous tissue and a portion of the lumbodorsal muscles at a point of 1 cm to the
      pedicle projection point. In the CLIA group, the needle was directed towards the laminar
      periosteum at the pedicular projection point at the 10-15 ° angle with the sagittal plane. A
      mixture of 6 mL of 1% Lidocaine Hydrochloride and 14 mL of 0.5% bupivacaine will be applied.

      The anesthesia process of the CLIA + EPIA group also includes the third step called EPIA. For
      this stage, the anesthetic needle is first drawn into the subcutaneous tissue, then through
      the lateral superior articular process to the lateral half of the pedicle and the upper
      border of the transverse process (5-10 degrees with sagittal plane and 5-10 with coronal
      plane), and after negative aspiration 3 mL 1% Lidocaine Hydrochloride and 7 mL 0.5%
      bupivacaine mixture will be applied bilaterally. In the ESP group, a high-frequency 15-6
      megahertz linear ultrasound probe will be placed vertically approximately 3 cm laterally at
      the point of application. Once the erector spinae muscle and transverse process have been
      identified, the peripheral nerve blockage needle (50 mm 22 G ) will be advanced from caudal
      to cranial between the fascia of the erector spina muscle and the transverse process. After 1
      ml normal saline injection, this plane was opened. 6 mL of 1% Lidocaine Hydrochloride and 14
      mL of 0.5% bupivacaine will be administered. The entire dose of Lidocaine Hydrochloride shall
      not exceed 300 mg or <4.5 mg / kg. The degree of pain in the intraoperative period will be
      assessed using a numerical rating scale. Each patient will receive a brief preoperative
      training to know that NRS 0 is not pain, 10 is maximum pain, and that they will be asked to
      report their pain using this scale. Patients with severe pain (NRS> 4) will receive 50
      micrograms of fentanyl as an additional analgesic. Sedation levels of the patients will be
      evaluated with ramsey sedation scale (1-6). Patients with a sedation score of 1 will receive
      2 mg of midazolam. The sedation level will be aimed at Ramsey 2-3. Hemodynamic assessments
      during the procedure will be recorded. Mean arterial pressures (mean blood pressure), heart
      rate and oxygen saturation (SpO2) will be recorded.

      During the procedure, pain scores at 0 minutes, 15, 30 and 45 minutes, sedation scores,
      additional analgesic and sedation amounts administered, and hemodynamic parameters will be
      recorded. The statistical difference between the groups will be compared.

CLIA Group (conventional local anesthesia infiltration)

EPIAA Group (Extrapedicular infiltration anesthesia)

ESP Group (Erector Spina Block)

Investigation of the Effectiveness of Erector Spinae Plane Block in Patients Undergoing Kyphoplasty

numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)

Ramsay Sedation Scale divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. Level 1: Patient awake, anxious, agitated, or restless, level 2 :Patient awake, cooperative, orientated, and tranquil, Level 3: Patient drowsy, with response to commands Level 4: Patient asleep, brisk response to glabella tap or loud auditory stimulus Level 5:Patient asleep, sluggish response to stimulus, Level 6:Patient has no response to firm nail-bed pressure or other noxious stimuli

mean arterial blood pressures measured noninvasively will be recorded

oxygen saturation measured by pulseoximeter will be recorded

heart rate measured by electrocardiogram will be recorded

Assistant professor

The first step was to determine the pedicle to be vertebroplasty, and 5 mL of 1% Lidocaine Hydrochloride bilaterally to infiltrate the skin, subcutaneous tissue and a portion of the lumbodorsal muscles from a point of 1 cm to the pedicle projection point.
In the CLIA group, the needle (50 mm 22 Gauge) was directed towards the laminar periosteum at the pedicular projection point at the 10-15 ° angle with the sagittal plane. A mixture of 3 mL of 2% Lidocaine Hydrochloride and 7 mL of 0.5% bupivacaine will be applied bilaterally.

The first step was to determine the pedicle to be vertebroplasty, and 5 mL of 1% Lidocaine Hydrochloride bilaterally to infiltrate the skin, subcutaneous tissue and a portion of the lumbodorsal muscles from a point of 1 cm to the pedicle projection point.
The anesthesia process of the CLIA + EPIA group also includes the third step called EPIA. For this stage, the anesthetic needle (50 mm 22 Gauge) is first drawn into the subcutaneous tissue, then through the lateral superior articular process to the lateral half of the pedicle and the upper border of the transverse process (5-10 degrees with sagittal plane and 5-10 with coronal plane), and after negative aspiration 3 mL 2% Lidocaine Hydrochloride and 7 mL 0.5% bupivacaine mixture will be applied bilaterally

The first step was to determine the pedicle to be vertebroplasty, and 5 mL of 1% Lidocaine Hydrochloride bilaterally to infiltrate the skin, subcutaneous tissue and a portion of the lumbodorsal muscles from a point of 1 cm to the pedicle projection point.
In the ESP group, a high-frequency-50 15-6 Megahertz (MHz) linear ultrasound probe will be placed vertically approximately 3 cm laterally at the point of application. Once the erector spinae muscle and transverse process have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml normal saline injection, this plane was opened. Bilateral 3 mL of 2% Lidocaine Hydrochloride and 7 mL of 0.5% bupivacaine will be administered.

Effectiveness of Erector Spinae Block in Kyphoplasty

About this trial

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Placebo

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