- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT06779604
Dexmedetomidin és dexametazon adjuváns infraclavicularis brachialis plexus blokkként a felső végtagi sebészetben
A dexmedetomidin és a dexametazon érzéstelenítő hatásának összehasonlítása, adjuvánsként az ultrahanggal vezérelt infraclavicularis brachialis plexus blokkhoz a felső végtagi sebészetben
The aim of this study was to investigate the effect of dexmedetomidine and dexamethasone added during USG-guided infraclavicular block on block onset time, total block time and time to first analgesic need in patients undergoing upper extremity surgery.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Brachial plexus blocks are successfully applied for perioperative/postoperative analgesia in upper extremity surgical procedures. These blocks include infraclavicular, supraclavicular, interscalene, and axillary blocks. The reason why infraclavicular block is preferred is that it provides comprehensive anesthesia/analgesia of the upper extremity. While the axillary approach may fail to block the musculocutaneous nerve that causes tourniquet pain, the interscalene and supraclavicular approaches generally fail to provide anesthesia in the distribution of the ulnar nerve. Other advantages include the lower risk of lung and pleural puncture compared to interscalene and supraclavicular blocks and the lower probability of injury to neurovascular structures due to the location of the block, unlike the interscalene approach.
Local anesthetics are used to block conduction in nerve fibers during brachial plexus blocks. Studies have shown that the commonly used bupivacaine and ropivacaine 0.25% concentrations are not recommended for anesthesia. Bupivacaine 0.5% and ropivacaine 0.5% have been shown to be similar in terms of sensory and motor block onset time, total sensory and motor block duration, analgesia duration, anesthesia duration, paresis and paralysis incidence. The minimum dose of bupivacaine 0.5% required for complete sensory block was determined as 14mL, but the onset time of the block performed at this low dose was recorded as a late onset of 40 minutes (30-45 minutes). It was observed that the onset time decreased to as short as 15 minutes (min) after the application of 30mL bupivacaine 0.5%. In order to reduce the amount of local anesthetic used, to avoid local anesthetic toxicity, to shorten the block onset time and to extend the postoperative analgesia period, a different local anesthetic or adjuvants were used together with bupivacaine. Bupivacaine used with lidocaine has been observed to have a faster onset of action. Other adjuvants added to accelerate the onset of block and improve the quality of the block include alpha-2 agonists (clonidine and dexmedetomidine), opioids (fentanyl and tramadol), and steroids (dexamethasone). Dexmedetomidine is an adjuvant that is an alpha-2 adrenergic agonist and has been observed to have a synergistic effect with local anesthetics and to prolong their duration of activity. The addition of dexmedetomidine 50 µg and 75 µg has been associated with a decrease in the time to onset of sensory and motor block, a decrease in postoperative morphine consumption, and an increase in the duration of sensory block, motor block, and the time to first morphine request. Dexmedetomidine 75 µg has been associated with an increased incidence of preoperative and intraoperative hypotension episodes. Dexamethasone, a perineural adjuvant, has been shown in many studies to significantly shorten the onset of sensory and motor block and prolong the duration of analgesia. Perineural dexamethasone is more commonly used intravenously for block. Currently, many studies have compared the effects of various perineural dexamethasone doses, such as 1 mg, 2 mg, 4 mg, 5 mg and 8 mg, on block, but the results remain controversial. Studies have shown that there is no difference in safety and efficacy between 4 and 8 mg perineural dexamethasone. Another study reported that 4 mg perineural dexamethasone constitutes a ceiling dose for prolonging the duration of analgesia when used with local anesthetics for block.
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
-
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Umraniye
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Istanbul, Umraniye, Törökország (Türkiye), 34034
- Umraniye Education and Research Hospital
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
A total of 44 adult patients 18 to 70 years, American Society of Anesthesiologists (ASA) I-II who underwent upper extremity surgery were included in Orthopedics and Traumatology Clinic.
Leírás
Inclusion Criteria:
- 18-70 years
- ASA I-II
Exclusion Criteria:
- Under 18 years of age and older than 70 years of age,
- presence of brachial plexus injury,
- patients with bleeding diathesis,
- presence of allergy, -contralateral diaphragmatic paralysis, -
- presence of nerve injury secondary to trauma,
- pre-existing neuropathy of the surgical extremity,
- presence of severe pulmonary,
- renal and hepatic disease,
- congestive heart failure (NYHA stage 3-4),
- uncontrolled diabetes mellitus,
- history of neuromuscular disease,
- patients with extreme obesity or malnutrition (BMI > 30 kg-1m2 or BMI <20 kg-1m2),
- presence of epilepsy,
- history of peripheral vascular disease,
- history of chronic pain or fibromyalgia,
- pregnant and lactating patients,
- patients with local infection at the injection site,
- patients undergoing general anesthesia due to inadequacy of the block,
- patients refusing to give informed consent,
- history of recreational substance use, and chronic narcotic-based painkillers
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: CASE_CONTROL
- Időperspektívák: PROSPECTIVE
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
Group Dexmedetomidine: (n:22)
A total volume of 30 mL of 0.5% bupivacaine, 14 mL of 2% lidocaine and 50 μgr of dexmedetomidine in 1 mL of normal saline is administered to the patients. |
Infraclavicular block with Dexmedetomidine and Dexamethasone was performed at least 30 min before the start of the operation. The patient was positioned in a supine position arms at the sides or in 90 degree abduction, head turned to the other side. Infraclavicular block was performed with the lateral sagittal technique, while the USG probe was placed under the clavicle and medial to the coracoid process, providing a brachial plexus image in the form of a hyperechoic outer ring and hypoechoic circles, like a classic honeycomb image. A local anesthetic mixture was injected with a 100 mm block needle with negative aspiration and its spread in tissue planes was observed. If the VAS score was 3 or above, tramadol 1 mg kg-1 was administered as an analgesic drug. |
|
GroupDexamethasone: (n:22)
Patients are administered 0.5% bupivacaine 15 mL, 2% lidocaine 14 mL and 4 mg dexamethasone in 1 ml normal saline with a total volume of 30 mL |
Infraclavicular block with Dexmedetomidine and Dexamethasone was performed at least 30 min before the start of the operation. The patient was positioned in a supine position arms at the sides or in 90 degree abduction, head turned to the other side. Infraclavicular block was performed with the lateral sagittal technique, while the USG probe was placed under the clavicle and medial to the coracoid process, providing a brachial plexus image in the form of a hyperechoic outer ring and hypoechoic circles, like a classic honeycomb image. A local anesthetic mixture was injected with a 100 mm block needle with negative aspiration and its spread in tissue planes was observed. If the VAS score was 3 or above, tramadol 1 mg kg-1 was administered as an analgesic drug. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
infraclavicular block onset time
Időkeret: 24 -48 hours
|
Sensory block / motor block onset time |
24 -48 hours
|
|
postoperative analgesic drug requirement
Időkeret: 24 -48 hours
|
opioid total amount micrograms |
24 -48 hours
|
|
infraclavicular total block time
Időkeret: 24 -48 hours
|
block time hours |
24 -48 hours
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
investigate the effects on VAS score and sedation level in the first 24 hours postoperatively
Időkeret: 24 -48 hours
|
VAS score |
24 -48 hours
|
|
advers event Perioperative and postoperative period
Időkeret: 24 -48 hours
|
Nausea,Vomiting,Hypotension,Bradycardia, Nerve damage |
24 -48 hours
|
Együttműködők és nyomozók
Nyomozók
- Tanulmányi igazgató: ZELİHA TUNCEL, ASC PROF, Umraniye ERH
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Fájdalom
- Neurológiai megnyilvánulások
- Posztoperatív szövődmények
- Patológiás folyamatok
- Kóros állapotok, jelek és tünetek
- Jelek és tünetek
- Fájdalom, posztoperatív
- Akut fájdalom
- Heterociklusos vegyületek, 1 gyűrű
- Heterociklusos vegyületek
- Azolok
- Policiklusos vegyületek
- Imidazolok
- Terhesség
- Terhesség
- Szteroidok
- Olvasztott gyűrűs vegyületek
- Szteroidok, fluortartalmú
- Remoklóriumok
- Dexametazon
- Dexmedetomidin
Egyéb vizsgálati azonosító számok
- UERH-AR-ZT-11
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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