Spinal FracturesNCT04201678
Effectiveness of Erector Spinae Block in Kyphoplasty
A study testing CLIA Group (conventional local anesthesia infiltration), EPIAA Group (Extrapedicular infiltration anesthesia) and ESP Group (Erector Spina Block) in people with Spinal Fractures and Anesthesia, Regional, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Spinal Fractures, Anesthesia, Regional, Anesthetics, Local
- What is being tested?
- CLIA Group (conventional local anesthesia infiltration), EPIAA Group (Extrapedicular infiltration anesthesia) and ESP Group (Erector Spina Block)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The American Society of Anesthesiologists (ASA) score I-III
- 40-80 years old
Who cannot join
- ASA >III,
- receiving chronic pain treatment
- previous lumbar surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, Keçiören, 06100
About this study
Official title: 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
Read the 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.
- Conditions
- Spinal Fractures, Anesthesia, Regional, Anesthetics, Local, Analgesia
- Being tested
- CLIA Group (conventional local anesthesia infiltration), EPIAA Group (Extrapedicular infiltration anesthesia), ESP Group (Erector Spina Block)
- Keywords
- Kyphoplasty, Erector Spinae Block, conventional local infiltration anesthesia, Extrapedicular infiltration anesthesia
- Medical subject headings
- Spinal Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLIA Group (conventional local anesthesia infiltration)Procedure or surgery
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.
EPIAA Group (Extrapedicular infiltration anesthesia)Procedure or surgery
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
ESP Group (Erector Spina Block)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Procedure: ESP Group (Erector Spina Block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale (NRS)
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: RSS score at 45. minutes during the kyphoplasty.
Mean Arterial Pressure (MAP)
mean arterial blood pressures measured noninvasively will be recorded
Measured: MAP at 0. minutes during the kyphoplasty.
Mean Arterial Pressure (MAP)
mean arterial blood pressures measured noninvasively will be recorded
Measured: MAP at 15. minutes during the kyphoplasty.
Mean Arterial Pressure (MAP)
mean arterial blood pressures measured noninvasively will be recorded
Measured: MAP at 30. minutes during the kyphoplasty.
Mean Arterial Pressure (MAP)
mean arterial blood pressures measured noninvasively will be recorded
Measured: MAP at 45. minutes during the kyphoplasty.
SpO2 (Oxygen saturation)
oxygen saturation measured by pulseoximeter will be recorded
Measured: SpO2 value at 0. minutes during the kyphoplasty.
SpO2 (Oxygen saturation)
oxygen saturation measured by pulseoximeter will be recorded
Measured: SpO2 value at 15. minutes during the kyphoplasty.
SpO2 (Oxygen saturation)
oxygen saturation measured by pulseoximeter will be recorded
Measured: SpO2 value at 30. minutes during the kyphoplasty.
SpO2 (Oxygen saturation)
oxygen saturation measured by pulseoximeter will be recorded
Measured: SpO2 value at 45. minutes during the kyphoplasty.
Heart rate (HR)
heart rate measured by electrocardiogram will be recorded
Measured: HR at 0. minutes during the kyphoplasty.
Heart rate (HR)
heart rate measured by electrocardiogram will be recorded
Measured: HR at 15. minutes during the kyphoplasty.
Heart rate (HR)
heart rate measured by electrocardiogram will be recorded
Measured: HR at 30. minutes during the kyphoplasty.
Heart rate (HR)
heart rate measured by electrocardiogram will be recorded
Measured: HR at 45. minutes during the kyphoplasty.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start23 Oct 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Burak Eşkin, Gulhane School of Medicine
- Investigators
- Mehmet B EŞKİN, Study director, Gulhane Training and Research HospitalAyşegül Ceylan, Principal investigator, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201678
- Sponsor's protocol ID
- 19/341
- Status last verified
- Jul 2020
- First submitted
- 4 Dec 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Erector Spinae Plane Block in Patients Undergoing Kyphoplasty
- ClinicalTrials.gov ID
- NCT04201678
- Acronym / sponsor ID
- 19/341
- Conditions
- Spinal Fractures, Anesthesia, Regional, Anesthetics, Local, Analgesia
- Keywords
- Kyphoplasty, Erector Spinae Block, conventional local infiltration anesthesia, Extrapedicular infiltration anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| CLIA (conventional local anesthesia infiltration) Group | Active comparator | 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. |
| EPIAA (Extrapedicular infiltration anesthesia) Group | Active comparator | 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 |
| ESP (Erector Spina Plane Block) Group | Active comparator | 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 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The American Society of Anesthesiologists (ASA) score I-III
- 40-80 years old
Key exclusion criteria (3 listed)
- ASA >III,
- receiving chronic pain treatment
- previous lumbar surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | CLIA (conventional local anesthesia infiltration) Group |
| 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 | Procedure or surgery | EPIAA (Extrapedicular infiltration anesthesia) Group |
| 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. | Procedure or surgery | ESP (Erector Spina Plane Block) Group |
Primary outcome
numeric rating scale (NRS)
Time frame: NRS pain score at 0. minutes during the kyphoplasty.
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
numeric rating scale (NRS)
Time frame: NRS pain scores at 15. minutes during the kyphoplasty
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
numeric rating scale (NRS)
Time frame: NRS pain score at 30. minutes during the kyphoplasty.
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
numeric rating scale (NRS)
Time frame: NRS pain score at 45. minutes during the kyphoplasty.
numerical rating pain scale (0 = no pain, 10 = maximum pain to be considered)
ramsey sedation scale (RSS)
Time frame: RSS score at 0. minutes during the kyphoplasty.
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)
Time frame: RSS score at 15. minutes during the kyphoplasty.
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)
Time frame: RSS score at 30. minutes during the kyphoplasty.
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)
Time frame: RSS score at 45. minutes during the kyphoplasty.
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)
Time frame: MAP at 0. minutes during the kyphoplasty.
mean arterial blood pressures measured noninvasively will be recorded
Mean Arterial Pressure (MAP)
Time frame: MAP at 15. minutes during the kyphoplasty.
mean arterial blood pressures measured noninvasively will be recorded
Mean Arterial Pressure (MAP)
Time frame: MAP at 30. minutes during the kyphoplasty.
mean arterial blood pressures measured noninvasively will be recorded
Mean Arterial Pressure (MAP)
Time frame: MAP at 45. minutes during the kyphoplasty.
mean arterial blood pressures measured noninvasively will be recorded
SpO2 (Oxygen saturation)
Time frame: SpO2 value at 0. minutes during the kyphoplasty.
oxygen saturation measured by pulseoximeter will be recorded
SpO2 (Oxygen saturation)
Time frame: SpO2 value at 15. minutes during the kyphoplasty.
oxygen saturation measured by pulseoximeter will be recorded
SpO2 (Oxygen saturation)
Time frame: SpO2 value at 30. minutes during the kyphoplasty.
oxygen saturation measured by pulseoximeter will be recorded
SpO2 (Oxygen saturation)
Time frame: SpO2 value at 45. minutes during the kyphoplasty.
oxygen saturation measured by pulseoximeter will be recorded
Heart rate (HR)
Time frame: HR at 0. minutes during the kyphoplasty.
heart rate measured by electrocardiogram will be recorded
Heart rate (HR)
Time frame: HR at 15. minutes during the kyphoplasty.
heart rate measured by electrocardiogram will be recorded
Heart rate (HR)
Time frame: HR at 30. minutes during the kyphoplasty.
heart rate measured by electrocardiogram will be recorded
Heart rate (HR)
Time frame: HR at 45. minutes during the kyphoplasty.
heart rate measured by electrocardiogram will be recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet B EŞKİN study director
Gulhane Training and Research Hospital
Ayşegül Ceylan principal investigator
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLIA Group (conventional local anesthesia infiltration), EPIAA Group (Extrapedicular infiltration anesthesia) and ESP Group (Erector Spina Block) in people with Spinal Fractures and Anesthesia, Regional, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numeric rating scale (NRS) (time frame: NRS pain score at 0. minutes during the kyphoplasty.). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.