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Comparison of Infraclavicular And Supraclavicular Block

2. März 2021 aktualisiert von: Mehmet Emre Şen, Bozyaka Training and Research Hospital

Comparison of Infraclavicular and Supraclavicular Block Approaches in Ultrasound Guided Brachial Plexus Block

Ultrasound-guided brachial plexus blocks are used successfully for upper extremity surgeries. In this randomized prospective single-blind study, ASA I-II patients aged 18-65 years undergoing hand, wrist, and forearm surgery will be randomly divided into two groups. First group will receive ultrasound-guided coronal oblique supraclavicular block using a 22G, 50 mm stimulator needle, and the second group, ultrasound-guided lateral sagittal infraclavicular block using a 22G 100 mm stimulator needle. We will prepare, 30 ml of 1:1 0.5% bupivacaine and 2% prilocaine with 5 mcg adrenaline per milliliter as local anesthetic mixture. Block application time, block success, sensory and motor block levels, and postoperative analgesia time will be recorded and compared between the groups. Accordingly, the success rate of the two methods will be evaluated.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

70

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • Karabağlar
      • Izmir, Karabağlar, Truthahn, 35170
        • Izmir Bozyaka Training and Research Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.)
Andere Namen:
  • Bupivacain 0,5 %
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.)
Andere Namen:
  • Priloc %2
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.)
Andere Namen:
  • Adrenalin codex 0.5 mg 1 ml injectable solution
The blocks will be performed by an experienced anesthesiologist with a USG guidence.
Experimental: 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.)
Andere Namen:
  • Bupivacain 0,5 %
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.)
Andere Namen:
  • Priloc %2
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.)
Andere Namen:
  • Adrenalin codex 0.5 mg 1 ml injectable solution
The blocks will be performed by an experienced anesthesiologist with USG guidence.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Block Formation Time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The Motor Block Level 10th minute
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienstuhl: Mehmet E Şen, MD, Izmir Bozyaka Training and Research Hospital
  • Studienstuhl: Zeki T Tekgül, Assoc Prof, Izmir Bozyaka Training and Research Hospital
  • Studienstuhl: Taşkın Altay, Assoc Prof, Izmir Bozyaka Training and Research Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

5. März 2021

Primärer Abschluss (Voraussichtlich)

15. August 2021

Studienabschluss (Voraussichtlich)

1. September 2021

Studienanmeldedaten

Zuerst eingereicht

2. März 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. März 2021

Zuerst gepostet (Tatsächlich)

5. März 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. März 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. März 2021

Zuletzt verifiziert

1. März 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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