Terminé

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

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Ce qui est testé

CLIA Group (conventional local anesthesia infiltration)

+ EPIAA Group (Extrapedicular infiltration anesthesia)

+ ESP Group (Erector Spina Block)

Procédure
Qui peut participer

Agnosie+9

+ Maladies du système nerveux

+ Manifestations Neurologiques

De 40 à 80 ans
+5 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : octobre 2019
Voir le détail du protocole

Résumé

Sponsor principalGulhane School of Medicine
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 23 octobre 2019

Date à laquelle le premier participant a commencé l'étude.

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.

Titre officielInvestigation of the Effectiveness of Erector Spinae Plane Block in Patients Undergoing Kyphoplasty
Sponsor principalGulhane School of Medicine
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

90 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.


Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 40 à 80 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

AgnosieMaladies du système nerveuxManifestations NeurologiquesTroubles PerceptuelsSignes et symptômesBlessures de la colonne vertébraleConditions pathologiques, signes et symptômesBlessures et lésionsFractures de la colonne vertébraleBlessures du dosManifestations NeurocomportementalesFractures osseuses

Critères

2 critères d'inclusion nécessaires pour participer
The American Society of Anesthesiologists (ASA) score I-III

40-80 years old

3 critères d'exclusion empêchent la participation
ASA >III,

receiving chronic pain treatment

previous lumbar surgery

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

3 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Comparateur actif
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.

Groupe II

Comparateur actif
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

Groupe III

Comparateur actif
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.

Objectifs de l'étude

Objectifs principaux

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)Ouvrir Gulhane Training and Research Hospital dans Google Maps
Terminé1 Centres d'Étude