Hemidiaphragmatic Paralysis Following Supraclavicular Brachial Plexus Blockade.

July 8, 2024 updated by: Abanoub Youssief Mosaad, Sohag University

Hemidiaphragmatic Paralysis Following Ultrasound-Guided Supraclavicular Brachial Plexus Blockade in Patients Undergoing Upper Limb Surgery

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.

Study Overview

Status

Not yet recruiting

Detailed Description

The brachial plexus is formed by the anterior primary rami of C5 through T1 and provides sensory and motor innervation of the upper extremity. The brachial plexus is divided, proximally to distally, into rami/roots, trunks, divisions, cords, and terminal branches. The trunks can be found within the posterior triangle of the neck, between the anterior and middle scalene muscles. The brachial plexus, along with the axillary artery, can be considered as a large neurovascular bundle that travels in the axilla to supply the upper extremity.

The brachial plexus provides somatic motor and sensory innervation to the upper extremity, including the scapular region. As the brachial plexus travels through the posterior triangle of the neck into the axilla, arm, forearm, and hand, it contains various named regions based on how the plexus is formed. Ventral rami from spinal nerves C5 through T1, often referred to as roots of the brachial plexus, come together to allow their fibers to intermingle, forming superior, inferior, and middle trunks.

The 3 trunks continue from the posterior triangle into the axilla, with C5 and C6 roots forming the superior trunk, C8 and T1 roots forming the inferior trunk, and the C7 root continuing as the middle trunk.

Continuing from the trunks are bundles that are called divisions. Each of the trunks of the brachial plexus continues as an anterior and posterior division to form lateral, posterior, and medial cords.

The phrenic nerve Comprised of the anterior branches of the C3-C5 spinal roots, the phrenic nerve usually lies on the surface of the anterior scalene muscle underneath the sternocleidomastoid muscle before it enters the thorax behind the subclavian vein, although anatomic variations are common. Because of its close proximity to the brachial plexus, Phrenic nerve palsy (PNP) resulting in ipsilateral hemi diaphragmatic paralysis which can occur following brachial plexus blockade.

Hemi diaphragmatic paralysis (HdP) due to inadvertent phrenic nerve palsy (PNP) is a well-recognized complication of brachial plexus blockade, the incidence of PNP has been reported to be as high as 100% following interscalene brachial plexus block and 50% to 67% following supraclavicular block. While PNP is generally considered rare following infraclavicular block, the incidence prior to the widespread adoption of ultrasound-guided regional anesthesia using solely landmark-based or nerve-stimulator techniques has been reported as high as 26%.

As the brachial plexus and phrenic nerve diverge from each other as they move caudally, ultrasound-guided Supraclavicular Block (SCB) could be a safe, reliable and effective alternative.

Ultrasonography of the diaphragmatic dome is a straight-forward, reliable, non-invasive and reproducible method for assessing the activity of the diaphragm. In fact, Motion- mode can be used to assess diaphragmatic excursion (i.e., displacement) during a voluntary sniff test for which patients forcefully inhaled through the nose in a sniffing fashion. This study will be conducted to evaluate the incidence of hemi diaphragmatic paralysis following ultrasound-guided supraclavicular plexus blockade.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmed E Abd-elrahmaan, Prof
  • Phone Number: 01118011611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Hemidiaphragmatic Paralysis Following Ultrasound-Guided Supraclavicular Brachial Plexus Blockade in patients undergoing upper limb surgery
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.
Hemidiaphragmatic Paralysis Following Ultrasound-Guided Supraclavicular Brachial Plexus Blockade in patients undergoing upper limb surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidences of hemi diaphragmatic paralysis following ultrasound-guided supraclavicular plexus blockade
Time Frame: 2 hours
By Using M-mode Ultrasonography showing the limitation of diaphragmatic motion before and after supraclavicular brachial plexus blockade
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of post operative pain by visual analog scale
Time Frame: 2 hours
effect on vital signs
2 hours
Evaluation of oxygen saturation by pulse oximeter
Time Frame: 2 hours
effect on vital signs
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Magdy M Amin, Professor, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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