- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04784104
Comparison of Infraclavicular And Supraclavicular Block
Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block
Přehled studie
Postavení
Podmínky
Detailní popis
In this prospective single-blind study, patients will be divided into 2 groups with the closed envelope method. Patients will be taken to the block application room before the operation. Standard monitoring (pulse oximetry, noninvasive blood pressure, ECG) will be applied to the patients. Premedication will be provided with 1mg IV midazolam after peripheral vascular access. Blocks will be performed by an experienced anesthesiologist under the guidance of USG and evaluated by another anesthesiologist who is blind to the block technique. After the antisepsis of the area, a 22G 100 mm stimulator needle will be used in the infraclavicular approach and a 22G 50 mm in the supraclavicular block. Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture. 30 ml of 1:1 0.5% bupivacaine and 2% prilocaine plus 5 mcg adrenaline per ml will be used as local anesthetic mixture. The infraclavicular block will be applied by the lateral sagittal method under USG guidance. Supraclavicular block will be applied in the coronal oblique plane while the probe is placed on the clavicle. Following the blocks, the 5th, 10th, 15th, 20th, 25th, and 30th-minute sensory block levels, 10th, 20th, and 30th-minute motor block levels will be recorded. Sensory block level; Axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded. (0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain). The motor block will be evaluated with a modified bromage scale: 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
Block success; At the 30th minute of LA application, the pinprick test will define the presence of insensibility or only a sense of touch in the musculocutaneous, radial, ulnar, median, cutaneous antebrachii nerves. If any of these nerves are not blocked, it will be considered a failed block.
Postoperative analgesia time; It will be considered as when the NRS(Numeric Rating Scale) is≥1.
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS scores at the 2nd, 6th, 12th, 24th hours.
Sensory (the time from local anesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anesthetic injection until the patient's upper extremity regains full muscle strength) block time will be recorded as the block return time. Pain score during block application will be evaluated with the NRS. Block application time will be defined as the time from the moment the needle passes the skin until the local anesthetic is given and withdrawn. Block formation time will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves. Patient and surgeon satisfaction will be evaluated as 1 = complete dissatisfaction, 2 = moderate satisfaction, 3 = full satisfaction, after the procedure. Patients will be followed up for 24 hours in terms of undesirable side effects, vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and horner syndrome. As rescue anesthesia, sedoanalgesia will be tried with remifentanil infusion, if it is not successful, general anesthesia will be started with a laryngeal mask. As postoperative analgesic regimen, patients will receive 3 x 1000 mg IV acetaminophen. As rescue analgesia, Tramadol 1 mg/kg IV will be ordered to be administered when the patient's NRS is 3 or more. The first time when the patient receives rescue analgesia and the total dose of rescue analgesia for the first 24 hours will be recorded.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Mehmet E Şen, MD
- Telefonní číslo: +905436838272
- E-mail: m_emre_sen@hotmail.com
Studijní záloha kontaktů
- Jméno: Zeki T Tekgül, Assoc Prof
- Telefonní číslo: +905058554705
- E-mail: zekitekgul@yahoo.com
Studijní místa
-
-
Karabağlar
-
Izmir, Karabağlar, Krocan, 35170
- Izmir Bozyaka Training and Research Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 18-65 years old
- ASA I-II
- Patients scheduled for hand, wrist, and forearm surgery
Exclusion Criteria:
- Uncoordinated patients
- Having a disease that prevents sensory block evaluation,
- Have coagulopathy,
- Known allergies to drugs to be used,
- Those with anatomical disorders at the application points
- Pregnant patients,
- Patients under 18 years of age,
- Patients with known local anesthetic allergy,
- Patients diagnosed with sepsis and bacteriemia,
- Skin infection at the injection site.
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 |
---|---|
Experimentální: Supraclaviculer block
The coronal oblique supraclavicular block will be applied to the first group with ultrasound guidance using a 22G 50 mm stimulator needle.
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine, 2 ml saline with 5 mcg adrenaline per ml.) Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.
|
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
Ostatní jména:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
Ostatní jména:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
Ostatní jména:
The blocks will be performed by an experienced anesthesiologist with a USG guidence.
|
Experimentální: Infraclaviculer block
The lateral sagittal infraclavicular block will be applied to the second group with ultrasound guidance using a 22G 100 mm stimulator needle.
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine, 2 ml saline with 5 mcg adrenaline per ml.).
Intermittent negative aspiration will be performed during all procedures to detect possible vascular puncture.
|
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
Ostatní jména:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
Ostatní jména:
30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml.
(14 ml.
bupivacaine, 14 ml.
prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
Ostatní jména:
The blocks will be performed by an experienced anesthesiologist with USG guidence.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Block Formation Time
Časové okno: 30th minute pre-operatively
|
Block formation time will be defined as the time required to initiate anesthesia and analgesia in all 5 distal nerves.
|
30th minute pre-operatively
|
Block Application Time
Časové okno: During Block Application
|
Block application time will be defined as the time from the moment the needle passes the skin until the local anesthetic is given and withdrawn.
|
During Block Application
|
Block success
Časové okno: At the 30th minute of LA application
|
Block success; at the 30th minute of local anesthesic application, the pinprick test will define the presence of insensibility or only a sense of touch in the musculocutaneous, radial, ulnar, median, cutaneous antebrachii nerves.
If any of these nerves are not blocked, it will be considered a failed block.
|
At the 30th minute of LA application
|
Sensory Block Level 5th minute
Časové okno: 5th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
5th minute
|
Sensory Block Level 10th minute
Časové okno: 10th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
10th minute
|
Sensory Block Level 15th minute
Časové okno: 15th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
15th minute
|
Sensory Block Level 20th minute
Časové okno: 20th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
20th minute
|
Sensory Block Level 25th minute
Časové okno: 25th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
25th minute
|
Sensory Block Level 30th minute
Časové okno: 30th minute
|
Sensory block level; axillary, median, radial, ulnar, musculocutaneous, cutaneous brachia, and cutaneous antebrachii medialis nerve level will be evaluated with the pinprick test and its level will be recorded.
(0 = painful, no block; 1 = partial block-analgesia, only tactile sensation; 2 = complete block, no pain).
|
30th minute
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
The Motor Block Level 10th minute
Časové okno: 10th minute
|
The motor block will be evaluated with a Modified Bromage Scale.
( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
)
|
10th minute
|
Postoperative Analgesia Time
Časové okno: 24 hours post-operatively
|
Postoperative analgesia time; It will be considered as when the NRS (Numeric Rating Scale) is≥1.
|
24 hours post-operatively
|
Pain Score Follow-up 2nd Hour
Časové okno: 2nd hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 2nd hour.
|
2nd hour
|
Block Return Time
Časové okno: 24 hours postoperatively
|
Sensory (the time from local anaesthetic injection until the patient fully perceives the upper limb) and motor (the time from local anaesthetic injection until the patient's upper extremity regains full muscle strength) block time will be recorded as the block return time.
|
24 hours postoperatively
|
Patient and Surgeon Satisfaction
Časové okno: Immediately after the surgery
|
Patient and surgeon satisfaction will be evaluated as 1 = complete dissatisfaction, 2 = moderate dissatisfaction, 3 = moderate satisfaction 4 =full satisfaction, after the procedure.
|
Immediately after the surgery
|
Undesirable Side Effects
Časové okno: 24 hours postoperatively
|
Patients will be followed up for 24 hours in terms of undesirable side effects, vascular puncture, hematoma, signs of LA toxicity, respiratory distress, pneumothorax, and horner syndrome.
|
24 hours postoperatively
|
The Rescue Analgesia
Časové okno: 24 hours postoperatively
|
As rescue analgesia, Tramadol 1 mg/kg IV will be ordered to be administered when the patient's NRS is 3 or more.
The first time when the patient receives rescue analgesia will be recorded.
|
24 hours postoperatively
|
24-Hour Total Opioid Consumption
Časové okno: 24 hours postoperatively
|
The total dose of rescue analgesia (Tramadol ) for the first 24 hours will be recorded.
|
24 hours postoperatively
|
Pain Score Follow-up 6th Hour
Časové okno: 6th Hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 6th hour.
|
6th Hour
|
Pain Score Follow-up 12th Hour
Časové okno: 12th Hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 12th hour.
|
12th Hour
|
Pain Score Follow-up 24th Hour
Časové okno: 24th Hour
|
Pain Score Follow-up; patients' pain scores will be recorded by checking their NRS (Numeric Rating Scale) scores at the 24th hour.
|
24th Hour
|
The Motor Block Level 20th minute
Časové okno: 20th minute
|
The motor block will be evaluated with a Modified Bromage Scale.
( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
)
|
20th minute
|
The Motor Block Level 30th minute
Časové okno: 30th minute
|
The motor block will be evaluated with a Modified Bromage Scale.
( 0: No blocks, he can lift his arm; 1: Arm is weak but active; 2: Arm is motionless but fingers are active; 3: Complete block, no movement in hand or arm.
)
|
30th minute
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Mehmet E Şen, MD, Izmir Bozyaka Training and Research Hospital
- Studijní židle: Zeki T Tekgül, Assoc Prof, Izmir Bozyaka Training and Research Hospital
- Studijní židle: Taşkın Altay, Assoc Prof, Izmir Bozyaka Training and Research Hospital
Publikace a užitečné odkazy
Obecné publikace
- Gürkan Y, Hoşten T, Tekin M, Acar S, Solak M, Toker K. [Comparison of ultrasound-guided supraclavicular and infraclavicular approaches for brachial plexus blockade]. Agri. 2012;24(4):159-64. doi: 10.5505/agri.2012.38247. Turkish.
- Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
- Arcand G, Williams SR, Chouinard P, Boudreault D, Harris P, Ruel M, Girard F. Ultrasound-guided infraclavicular versus supraclavicular block. Anesth Analg. 2005 Sep;101(3):886-890. doi: 10.1213/01.ANE.0000159168.69934.CC.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
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
Klíčová slova
Další relevantní podmínky MeSH
- Patologické procesy
- Pooperační komplikace
- Bolest
- Neurologické projevy
- Bolest, pooperační
- Fyziologické účinky léků
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Depresiva centrálního nervového systému
- Autonomní agenti
- Agenti periferního nervového systému
- Agenti smyslového systému
- Anestetika
- Adrenergní alfa-agonisté
- Adrenergní agonisté
- Anestetika, lokální
- Bronchodilatační činidla
- Antiastmatická činidla
- Agenti dýchacího systému
- Adrenergní beta-agonisté
- Sympatomimetika
- Vazokonstrikční činidla
- Mydriatici
- Farmaceutická řešení
- Prilokain
- Bupivakain
- Epinefrin
- Racepinefrin
- Epinefrylboritan
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Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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