Clinical trial NCT04201678: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Fractures
Anesthesia, Regional
Anesthetics, Local
Analgesia
Keywords: Kyphoplasty
Erector Spinae Block
conventional local infiltration anesthesia
Extrapedicular infiltration anesthesia
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: numeric rating scale (NRS)
timeFrame: NRS pain score at 0. minutes during the kyphoplasty.
measure: numeric rating scale (NRS)
timeFrame: NRS pain scores at 15. minutes during the kyphoplasty
measure: numeric rating scale (NRS)
timeFrame: NRS pain score at 30. minutes during the kyphoplasty.
measure: numeric rating scale (NRS)
timeFrame: NRS pain score at 45. minutes during the kyphoplasty.
measure: ramsey sedation scale (RSS)
timeFrame: RSS score at 0. minutes during the kyphoplasty.
measure: ramsey sedation scale (RSS)
timeFrame: RSS score at 15. minutes during the kyphoplasty.
measure: ramsey sedation scale (RSS)
timeFrame: RSS score at 30. minutes during the kyphoplasty.
measure: ramsey sedation scale (RSS)
timeFrame: RSS score at 45. minutes during the kyphoplasty.
measure: Mean Arterial Pressure (MAP)
timeFrame: MAP at 0. minutes during the kyphoplasty.
measure: Mean Arterial Pressure (MAP)
timeFrame: MAP at 15. minutes during the kyphoplasty.
measure: Mean Arterial Pressure (MAP)
timeFrame: MAP at 30. minutes during the kyphoplasty.
measure: Mean Arterial Pressure (MAP)
timeFrame: MAP at 45. minutes during the kyphoplasty.
measure: SpO2 (Oxygen saturation)
timeFrame: SpO2 value at 0. minutes during the kyphoplasty.
measure: SpO2 (Oxygen saturation)
timeFrame: SpO2 value at 15. minutes during the kyphoplasty.
measure: SpO2 (Oxygen saturation)
timeFrame: SpO2 value at 30. minutes during the kyphoplasty.
measure: SpO2 (Oxygen saturation)
timeFrame: SpO2 value at 45. minutes during the kyphoplasty.
measure: Heart rate (HR)
timeFrame: HR at 0. minutes during the kyphoplasty.
measure: Heart rate (HR)
timeFrame: HR at 15. minutes during the kyphoplasty.
measure: Heart rate (HR)
timeFrame: HR at 30. minutes during the kyphoplasty.
measure: Heart rate (HR)
timeFrame: HR at 45. minutes during the kyphoplasty.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
state: Keçiören
Study officials:
affiliation: Gulhane Training and Research Hospital
name: Mehmet B EŞKİN
role: STUDY_DIRECTOR
affiliation: Gulhane Training and Research Hospital
name: Ayşegül Ceylan
role: PRINCIPAL_INVESTIGATOR
References: