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Effectiveness of Erector Spinae Block in Kyphoplasty

Primary Purpose

Spinal Fractures, Anesthesia, Regional, Anesthetics, Local

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
CLIA Group (conventional local anesthesia infiltration)
EPIAA Group (Extrapedicular infiltration anesthesia)
ESP Group (Erector Spina Block)
Sponsored by
Gulhane School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Fractures focused on measuring Kyphoplasty, Erector Spinae Block, conventional local infiltration anesthesia, Extrapedicular infiltration anesthesia

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gulhane Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

CLIA (conventional local anesthesia infiltration) Group

EPIAA (Extrapedicular infiltration anesthesia) Group

ESP (Erector Spina Plane Block) Group

Arm Description

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.

Outcomes

Primary Outcome Measures

numeric rating scale (NRS)
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
numeric rating scale (NRS)
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
numeric rating scale (NRS)
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
numeric rating scale (NRS)
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
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
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
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
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
Mean Arterial Pressure (MAP)
mean arterial blood pressures measured noninvasively will be recorded
Mean Arterial Pressure (MAP)
mean arterial blood pressures measured noninvasively will be recorded
Mean Arterial Pressure (MAP)
mean arterial blood pressures measured noninvasively will be recorded
Mean Arterial Pressure (MAP)
mean arterial blood pressures measured noninvasively will be recorded
SpO2 (Oxygen saturation)
oxygen saturation measured by pulseoximeter will be recorded
SpO2 (Oxygen saturation)
oxygen saturation measured by pulseoximeter will be recorded
SpO2 (Oxygen saturation)
oxygen saturation measured by pulseoximeter will be recorded
SpO2 (Oxygen saturation)
oxygen saturation measured by pulseoximeter will be recorded
Heart rate (HR)
heart rate measured by electrocardiogram will be recorded
Heart rate (HR)
heart rate measured by electrocardiogram will be recorded
Heart rate (HR)
heart rate measured by electrocardiogram will be recorded
Heart rate (HR)
heart rate measured by electrocardiogram will be recorded

Secondary Outcome Measures

Full Information

First Posted
December 4, 2019
Last Updated
July 20, 2020
Sponsor
Gulhane School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04201678
Brief Title
Effectiveness of Erector Spinae Block in Kyphoplasty
Official Title
Investigation of the Effectiveness of Erector Spinae Plane Block in Patients Undergoing Kyphoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fractures, Anesthesia, Regional, Anesthetics, Local, Analgesia
Keywords
Kyphoplasty, Erector Spinae Block, conventional local infiltration anesthesia, Extrapedicular infiltration anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be divided into three randomized groups according to anesthetic method with conventional local anesthesia infiltration (CLIA) method and extrapedicular infiltration anesthesia (EPIAA) and US guided erector spina group (ESP).
Masking
ParticipantCare Provider
Masking Description
participants and healthcare providers will not know which patient is in which group.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CLIA (conventional local anesthesia infiltration) Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EPIAA (Extrapedicular infiltration anesthesia) Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
ESP (Erector Spina Plane Block) Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
CLIA Group (conventional local anesthesia infiltration)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
EPIAA Group (Extrapedicular infiltration anesthesia)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
ESP Group (Erector Spina Block)
Intervention Description
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.
Primary Outcome Measure Information:
Title
numeric rating scale (NRS)
Description
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
Time Frame
NRS pain score at 0. minutes during the kyphoplasty.
Title
numeric rating scale (NRS)
Description
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
Time Frame
NRS pain scores at 15. minutes during the kyphoplasty
Title
numeric rating scale (NRS)
Description
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
Time Frame
NRS pain score at 30. minutes during the kyphoplasty.
Title
numeric rating scale (NRS)
Description
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
Time Frame
NRS pain score at 45. minutes during the kyphoplasty.
Title
ramsey sedation scale (RSS)
Description
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
Time Frame
RSS score at 0. minutes during the kyphoplasty.
Title
ramsey sedation scale (RSS)
Description
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
Time Frame
RSS score at 15. minutes during the kyphoplasty.
Title
ramsey sedation scale (RSS)
Description
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
Time Frame
RSS score at 30. minutes during the kyphoplasty.
Title
ramsey sedation scale (RSS)
Description
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
Time Frame
RSS score at 45. minutes during the kyphoplasty.
Title
Mean Arterial Pressure (MAP)
Description
mean arterial blood pressures measured noninvasively will be recorded
Time Frame
MAP at 0. minutes during the kyphoplasty.
Title
Mean Arterial Pressure (MAP)
Description
mean arterial blood pressures measured noninvasively will be recorded
Time Frame
MAP at 15. minutes during the kyphoplasty.
Title
Mean Arterial Pressure (MAP)
Description
mean arterial blood pressures measured noninvasively will be recorded
Time Frame
MAP at 30. minutes during the kyphoplasty.
Title
Mean Arterial Pressure (MAP)
Description
mean arterial blood pressures measured noninvasively will be recorded
Time Frame
MAP at 45. minutes during the kyphoplasty.
Title
SpO2 (Oxygen saturation)
Description
oxygen saturation measured by pulseoximeter will be recorded
Time Frame
SpO2 value at 0. minutes during the kyphoplasty.
Title
SpO2 (Oxygen saturation)
Description
oxygen saturation measured by pulseoximeter will be recorded
Time Frame
SpO2 value at 15. minutes during the kyphoplasty.
Title
SpO2 (Oxygen saturation)
Description
oxygen saturation measured by pulseoximeter will be recorded
Time Frame
SpO2 value at 30. minutes during the kyphoplasty.
Title
SpO2 (Oxygen saturation)
Description
oxygen saturation measured by pulseoximeter will be recorded
Time Frame
SpO2 value at 45. minutes during the kyphoplasty.
Title
Heart rate (HR)
Description
heart rate measured by electrocardiogram will be recorded
Time Frame
HR at 0. minutes during the kyphoplasty.
Title
Heart rate (HR)
Description
heart rate measured by electrocardiogram will be recorded
Time Frame
HR at 15. minutes during the kyphoplasty.
Title
Heart rate (HR)
Description
heart rate measured by electrocardiogram will be recorded
Time Frame
HR at 30. minutes during the kyphoplasty.
Title
Heart rate (HR)
Description
heart rate measured by electrocardiogram will be recorded
Time Frame
HR at 45. minutes during the kyphoplasty.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet B EŞKİN
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayşegül Ceylan
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Training and Research Hospital
City
Ankara
State/Province
Keçiören
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Erector Spinae Block in Kyphoplasty

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