Různé rychlosti injekce na místní anestetické šíření ESPB
Dopad různých rychlosti injekce na lokální anestetické šíření ultrazvukového erektoru rovinního bloku spinae
The aim of this clinical trial is to investigate the effect of different injection speeds on the spread of local anesthetic during ultrasound-guided erector spinae plane block (ESPB) in patients undergoing CT-guided lung nodule localization. The primary question addressed is whether a high injection speed (30 ml delivered within 30 seconds) produces a different local anesthetic distribution compared with a lower injection speed (30 ml delivered within 180 seconds).
Přehled studie
Detailní popis
Senventy-four patients were selected to undergo CT guided puncture localization of lung nodules under local anesthesia, and the patients were divided into groups using a computer-generated random number in a ratio of 1:1. To ensure objectivity, a nurse who was not involved in the study prepared a sealed opaque envelope containing grouping information. Patients were randomly divided into two groups: control group (group C, 37 patients), and experimental group (group S, 37 patients). All patients underwent ultrasound guided ESPB before CT-guided nodule localization. Ultrasound guided ESPB method: Using a high-frequency linear probe (5-13 MHz, Sonosite, USA), the probe is placed parallel to the spine on the surface of the transverse process tip of the seventh thoracic vertebrae. Under ultrasound, the transverse process and spinal muscles are clearly exposed. Then, a long beveled needle is used, and inserted from the cephalad to caudal with in-plane technique. After the needle tip reaches between the transverse process and erector spinae muscles, 2ml saline is injected using water separation technique to confirm the position of the needle tip, then injecting 30ml local anesthetic solution (0.75% ropivacaine 15ml+iohexol 15ml). In the control group, the injection is administered at a rate of 30 ml within 180 seconds. In the experimental group, the injection is delivered at a faster rate of 30 ml withinr 30 seconds. After 30 minutes of block completion, CT scan and puncture localization were performed, following with 3D reconstruction. The primary outcome was mixture spread to the paravertebral space.The second outcomes were as follow: 1.spread to the intercostal space. 2. spread to the epidural space 3.spread to the neural foramina 4. cranio-caudal spread
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Tao Shan
- Telefonní číslo: +8618852095135
- E-mail: shantao2021@163.com
Studijní místa
-
-
Jiangsu
-
Nanjing, Jiangsu, Čína
- Nábor
- Nanjing First Hospital
-
Kontakt:
- YING ZHANG
- Telefonní číslo: 025-52271064
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
Patients scheduled for CT-guided lung nodule localization under local anesthesia will be selected
- aged 18-80 years
- BMI 18-30 kg/m²
- ASA classification I-III
Exclusion Criteria:
- Allergy to the study drug or to local anesthetics
- History of opioid abuse
- Previous infection at the ESPB or PVB puncture site
- Peripheral neuropathy
- Dysfunction of blood coagulation
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Group C
A total of 30 ml of the local anesthetic solution (0.375% ropivacaine, comprising 15 ml ropivacaine and 15 ml iodinated contrast) is injected. In the Group C, the injection is administered within 180 seconds. |
Patients undergoing CT-guided lung nodule localization were selected for the study, and ultrasound-guided erector spinae plane block was performed before surgery with different injection speed. |
|
Experimentální: Group S
A total of 30 ml of the local anesthetic solution (0.375% ropivacaine, comprising 15 ml ropivacaine and 15 ml iodinated contrast) is injected. In the Group S, the injection is administered within 30 seconds. |
Patients undergoing CT-guided lung nodule localization were selected for the study, and ultrasound-guided erector spinae plane block was performed before surgery with different injection speed. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Spread of local anesthetic into the paravertebral space
Časové okno: 30 minutes after completion of the ESPB block
|
Observation of local anesthetic spread into the paravertebral space with CT by a researcher who was blinded to group allocation |
30 minutes after completion of the ESPB block
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Diffusion of local anesthetic into intercostal space
Časové okno: 30 minutes after completion of the block
|
The Incidence and thoracic level of local anesthetics to intercostal space was observed with CT by a researcher who was blinded to group allocation. |
30 minutes after completion of the block
|
|
Diffusion of local anesthetic into the epidural space
Časové okno: 30 minutes after completion of the block
|
Incidence and segment of local anesthetic spread into the epidural was assessed by a researcher who was blinded to group allocationTime Frame: 30 minute after completion of the block |
30 minutes after completion of the block
|
|
Diffusion of local anesthetic into the neural foramina
Časové okno: 30 minutes after completion of the block
|
Incidence and segment of local anesthetic spread into the neural foramina was assessed by a researcher who was blinded to group allocationTime Frame: 30 minute after completion of the block |
30 minutes after completion of the block
|
|
Cephalocaudal spread of local anesthetic
Časové okno: 30 minutes after completion of the block
|
Observation of local anesthetic spread cephalocaudally |
30 minutes after completion of the block
|
|
Loss to Cold Sensation of Skin
Časové okno: 30 minutes after block
|
The sensation to cold was assessed with ice. The area includes the anterior chest wall (midclavicular line), lateral chest wall (posterior axillary line), and posterior chest wall (paraspinal zone) by a researcher who was blinded to group allocation. |
30 minutes after block
|
|
NRS (Numeric Rating Scales) Score
Časové okno: 1 hour after CT-guided nodule localization
|
Numerical Rating Scale (NRS): This scale is composed of 11 numbers from 0 to 10, with higher numbers indicating greater pain intensity.Patients are required to select a number from 0 to 10 that best represents their current pain intensity based on patients' experience. |
1 hour after CT-guided nodule localization
|
|
Hemodynamic profile
Časové okno: Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
|
Hemodynamic changes(Heart rate ) during blockade procedure |
Heart rate changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
|
|
Hemodynamic profile
Časové okno: Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
|
Hemodynamic changes(Mean arterial pressure ) during blockade procedure |
Mean arterial pressure changes before blockade, 5minute after blockade, 10 minute after blockade, 20minute after blockade, 30minute after blockade
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Tao Shan, Nanjing First Hospital, Nanjing Medical University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- KY20250327-16
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .