Effectiveness of Erector Spinae Block in Kyphoplasty

NCT04201678 | Completed

• 1 other identifier: 19/341
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Fractures; Anesthesia, Regional; Anesthetics, Local; Analgesia

Keywords

Kyphoplasty; Erector Spinae Block; conventional local infiltration anesthesia; Extrapedicular infiltration anesthesia

Outcome Measures

Primary Outcomes (20)

• 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.

Study Arms (3)

CLIA (conventional local anesthesia infiltration) Group

ACTIVE COMPARATOR

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)

EPIAA (Extrapedicular infiltration anesthesia) Group

ACTIVE COMPARATOR

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)

ESP (Erector Spina Plane Block) Group

ACTIVE COMPARATOR

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)

Interventions

CLIA Group (conventional local anesthesia infiltration) PROCEDURE

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.

CLIA (conventional local anesthesia infiltration) Group

EPIAA Group (Extrapedicular infiltration anesthesia) PROCEDURE

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

EPIAA (Extrapedicular infiltration anesthesia) Group

ESP Group (Erector Spina Block) PROCEDURE

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.

ESP (Erector Spina Plane Block) Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, Keçiören, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Fractures; Agnosia

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehmet B EŞKİN

  Gulhane Training and Research Hospital

  STUDY DIRECTOR

• Ayşegül Ceylan

  Gulhane Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: participants and healthcare providers will not know which patient is in which group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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).

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 17, 2019
• Study Start: October 23, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)