NCT06491498

Brief Summary

The supraclavicular block is a regional anesthetic technique used as an alternative or adjunct to general anesthesia or used for postoperative pain control for upper extremity surgeries (mid-humerus through the hand). First introduced in 1911 by Kulenkampff as a landmark-based approach, the associated risk of pneumothorax was likely responsible for the technique falling out of favor. With the advent of ultrasonography, La Grange described the utilization of the Doppler probe to identify arteries in 1978. Contemporarily, Kapral and colleagues advocated for the dynamic use of ultrasound to guide needle advancement in the supraclavicular position. Colloquially known as the "spinal of the arm," the supraclavicular block is advantageous as the brachial plexus nerves are tightly packed in this approach and speed of onset is often rapidly achieved. However, because of this consolidated relationship, consider restricting volumes of local anesthesia to as low as possible to achieve goals, as compression ischemia may occur.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

June 3, 2024

Last Update Submit

July 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidences of hemi diaphragmatic paralysis following ultrasound-guided supraclavicular plexus blockade

    By Using M-mode Ultrasonography showing the limitation of diaphragmatic motion before and after supraclavicular brachial plexus blockade

    2 hours

Secondary Outcomes (2)

  • Evaluation of post operative pain by visual analog scale

    2 hours

  • Evaluation of oxygen saturation by pulse oximeter

    2 hours

Study Arms (2)

Group R in the right upper limb.

Group R (30) will receive 15 mL of 0.5% bupivacaine with dexametomidine by dose 1 μg / kg in the right upper limb.

Diagnostic Test: Supraclavicular Brachial Plexus Blockade

Groub L in the left upper limb.

Groub L (30) will receive 15 mL of 0.5% bupivacaine with dexametomidine by dose 1 μg / kg in the left upper limb.

Diagnostic Test: Supraclavicular Brachial Plexus Blockade

Interventions

Hemidiaphragmatic Paralysis Following Ultrasound-Guided Supraclavicular Brachial Plexus Blockade in patients undergoing upper limb surgery

Groub L in the left upper limb.Group R in the right upper limb.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Age between 18 and 60 years. American Society of Anesthesiologists physical status 1 to 3, Able to give informed consent. Body mass index (BMI) less than 35.

You may qualify if:

  • Age between 18 and 60 years. American Society of Anesthesiologists physical status 1 to 3, Able to give informed consent. Body mass index (BMI) less than 35.

You may not qualify if:

  • Patient refusal. Known/suspected allergy to local anesthetics Pregnancy Body mass index (BMI) greater than 35 kg/m2 Neuromuscular disease Obstructive or restrictive pulmonary disease Known or suspected PNP or diaphragmatic dysfunction Other medical or anatomic contraindication to brachial plexus blockade as judged by the investigator
  • local infection.
  • significant coagulation abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Bigeleisen PE. Anatomical variations of the phrenic nerve and its clinical implication for supraclavicular block. Br J Anaesth. 2003 Dec;91(6):916-7. doi: 10.1093/bja/aeg254.

    PMID: 14633767BACKGROUND
  • Rose M, Ness TJ. Hypoxia following interscalene block. Reg Anesth Pain Med. 2002 Jan-Feb;27(1):94-6. doi: 10.1053/rapm.2002.29709.

    PMID: 11799511BACKGROUND
  • Erickson JM, Louis DS, Naughton NN. Symptomatic phrenic nerve palsy after supraclavicular block in an obese man. Orthopedics. 2009 May;32(5):368. doi: 10.3928/01477447-20090501-02.

    PMID: 19472948BACKGROUND
  • Feigl GC, Litz RJ, Marhofer P. Anatomy of the brachial plexus and its implications for daily clinical practice: regional anesthesia is applied anatomy. Reg Anesth Pain Med. 2020 Aug;45(8):620-627. doi: 10.1136/rapm-2020-101435. Epub 2020 May 28.

    PMID: 32471922BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Magdy M Amin, Professor

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abanob Y Mosaad, Resident

CONTACT

Ahmed E Abd-elrahmaan, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Anesthesia and ICU department faculty of medicine, Sohag university

Study Record Dates

First Submitted

June 3, 2024

First Posted

July 9, 2024

Study Start

July 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

July 9, 2024

Record last verified: 2024-07