Effectiveness of Erector Spinae Block in Kyphoplasty

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

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

Study Overview

• Status: Completed
• Conditions: Analgesia; Spinal Fractures; Anesthesia, Regional; Anesthetics, Local
• Intervention / Treatment: Procedure: CLIA Group (conventional local anesthesia infiltration); Procedure: EPIAA Group (Extrapedicular infiltration anesthesia); Procedure: ESP Group (Erector Spina Block)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Keçiören
    • Ankara, Keçiören, Turkey, 06100
      • Gulhane Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The American Society of Anesthesiologists (ASA) score I-III
• 40-80 years old

Exclusion Criteria:

• ASA >III,
• receiving chronic pain treatment
• previous lumbar surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CLIA (conventional local anesthesia infiltration) Group; 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.	Procedure: CLIA Group (conventional local anesthesia infiltration); 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.
Active Comparator: EPIAA (Extrapedicular infiltration anesthesia) Group; 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	Procedure: EPIAA Group (Extrapedicular infiltration anesthesia); 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
Active Comparator: ESP (Erector Spina Plane Block) Group; 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.	Procedure: ESP Group (Erector Spina Block); 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numeric rating scale (NRS)	numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)	NRS pain score at 0. minutes during the kyphoplasty.
numeric rating scale (NRS)	numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)	NRS pain scores at 15. minutes during the kyphoplasty
numeric rating scale (NRS)	numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)	NRS pain score at 30. minutes during the kyphoplasty.
numeric rating scale (NRS)	numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)	NRS pain score at 45. minutes during the kyphoplasty.
ramsey sedation scale (RSS)	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	RSS score at 0. minutes during the kyphoplasty.
ramsey sedation scale (RSS)	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	RSS score at 15. minutes during the kyphoplasty.
ramsey sedation scale (RSS)	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	RSS score at 30. minutes during the kyphoplasty.
ramsey sedation scale (RSS)	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	RSS score at 45. minutes during the kyphoplasty.
Mean Arterial Pressure (MAP)	mean arterial blood pressures measured noninvasively will be recorded	MAP at 0. minutes during the kyphoplasty.
Mean Arterial Pressure (MAP)	mean arterial blood pressures measured noninvasively will be recorded	MAP at 15. minutes during the kyphoplasty.
Mean Arterial Pressure (MAP)	mean arterial blood pressures measured noninvasively will be recorded	MAP at 30. minutes during the kyphoplasty.
Mean Arterial Pressure (MAP)	mean arterial blood pressures measured noninvasively will be recorded	MAP at 45. minutes during the kyphoplasty.
SpO2 (Oxygen saturation)	oxygen saturation measured by pulseoximeter will be recorded	SpO2 value at 0. minutes during the kyphoplasty.
SpO2 (Oxygen saturation)	oxygen saturation measured by pulseoximeter will be recorded	SpO2 value at 15. minutes during the kyphoplasty.
SpO2 (Oxygen saturation)	oxygen saturation measured by pulseoximeter will be recorded	SpO2 value at 30. minutes during the kyphoplasty.
SpO2 (Oxygen saturation)	oxygen saturation measured by pulseoximeter will be recorded	SpO2 value at 45. minutes during the kyphoplasty.
Heart rate (HR)	heart rate measured by electrocardiogram will be recorded	HR at 0. minutes during the kyphoplasty.
Heart rate (HR)	heart rate measured by electrocardiogram will be recorded	HR at 15. minutes during the kyphoplasty.
Heart rate (HR)	heart rate measured by electrocardiogram will be recorded	HR at 30. minutes during the kyphoplasty.
Heart rate (HR)	heart rate measured by electrocardiogram will be recorded	HR at 45. minutes during the kyphoplasty.

Collaborators and Investigators

• Sponsor: Gulhane School of Medicine
• Investigators: Study Director: Mehmet B EŞKİN, Gulhane Training and Research Hospital; Principal Investigator: Ayşegül Ceylan, Gulhane Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 14, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Erector Spinae Block; Kyphoplasty; conventional local infiltration anesthesia; Extrapedicular infiltration anesthesia
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Spinal Injuries; Back Injuries; Spinal Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 19/341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No