Comparison of Infraclavicular And Supraclavicular Block

NCT04784104 | Unknown Phase 4 DMC

• 1 other identifier: SupraInfraTez
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia Conduction; Upper Extremity Surgery; Pain, Postoperative; Anesthesia and Analgesia; Nerve Block; Brachial Plexus Block

Keywords

Brachial plexus block; Nerve block

Outcome Measures

Primary Outcomes (9)

• Block Formation Time

  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

  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time will be defined as the time from the moment the needle passes the skin until the local anesthetic is given and withdrawn.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

  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

  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

  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

  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

  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

  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

  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

Secondary Outcomes (13)

• The Motor Block Level 10th minute

  10th minute

• Postoperative Analgesia Time

  24 hours post-operatively

• Pain Score Follow-up 2nd Hour

  2nd hour

• Block Return Time

  24 hours postoperatively

• Patient and Surgeon Satisfaction

  Immediately after the surgery

Study Arms (2)

Supraclaviculer block

EXPERIMENTAL

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.

Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Prilocaine HCl 2% Injectable solution; Drug: Adrenaline amp. 0.5 mg; Procedure: Ultrasound guided supraclavicular block with coronal oblique method

Infraclaviculer block

EXPERIMENTAL

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.

Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Prilocaine HCl 2% Injectable solution; Drug: Adrenaline amp. 0.5 mg; Procedure: Ultrasound guided lateral sagittal infraclavicular block

Interventions

Bupivacaine HCl 0.5% Injectable Solution DRUG

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.)

Also known as: Bupivacaine 0.5%

Infraclaviculer block; Supraclaviculer block

Prilocaine HCl 2% Injectable solution DRUG

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.)

Also known as: Priloc %2

Infraclaviculer block; Supraclaviculer block

Adrenaline amp. 0.5 mg DRUG

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.)

Also known as: Adrenalin codex 0.5 mg 1 ml injectable solution

Infraclaviculer block; Supraclaviculer block

Ultrasound guided supraclavicular block with coronal oblique method PROCEDURE

The blocks will be performed by an experienced anesthesiologist with a USG guidence.

Supraclaviculer block

Ultrasound guided lateral sagittal infraclavicular block PROCEDURE

The blocks will be performed by an experienced anesthesiologist with USG guidence.

Infraclaviculer block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• ASA I-II
• Patients scheduled for hand, wrist, and forearm surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, Karabağlar, 35170, Turkey (Türkiye)

Location

Related Publications (3)

• Gurkan Y, Hosten 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.

  PMID: 23364778 BACKGROUND

• 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.

  PMID: 30857608 BACKGROUND

• 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.

  PMID: 16116009 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine; Prilocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mehmet E Şen, MD

  Izmir Bozyaka Training and Research Hospital

  STUDY CHAIR

• Zeki T Tekgül, Assoc Prof

  Izmir Bozyaka Training and Research Hospital

  STUDY CHAIR

• Taşkın Altay, Assoc Prof

  Izmir Bozyaka Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Mehmet E Şen, MD

CONTACT

+905436838272; m_emre_sen@hotmail.com

Zeki T Tekgül, Assoc Prof

CONTACT

+905058554705; zekitekgul@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiology Resident

Model Details: The study covers 2 groups. Supraclavicular block will be applied to the first group and infraclavicular block will be applied to the second group.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: March 5, 2021
• Primary Completion: August 15, 2021
• Study Completion: September 1, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)