Respiratory DepressionNCT06491498
Hemidiaphragmatic Paralysis Following Supraclavicular Brachial Plexus Blockade.
An observational study of Respiratory Depression, run by Sohag University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Depression
- What is being tested?
- Supraclavicular Brachial Plexus Blockade
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Ahmed E Abd-elrahmaan, Prof contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiratory Depression
- Being tested
- Supraclavicular Brachial Plexus Blockade
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraclavicular Brachial Plexus BlockadeDiagnostic test
Hemidiaphragmatic Paralysis Following Ultrasound-Guided Supraclavicular Brachial Plexus Blockade in patients undergoing upper limb surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Supraclavicular Brachial Plexus Blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Secondary outcomes (2)
Evaluation of post operative pain by visual analog scale
effect on vital signs
Measured: 2 hours
Evaluation of oxygen saturation by pulse oximeter
effect on vital signs
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory DepressionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Youssief Mosaad, Sohag University
- Investigators
- Magdy M Amin, Professor, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491498
- Sponsor's protocol ID
- Soh-Med-24-05-14MS
- Status last verified
- Jul 2024
- First submitted
- 3 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 14633767Rose M, Ness TJ. Hypoxia following interscalene block. Reg Anesth Pain Med. 2002 Jan-Feb;27(1):94-6. doi: 10.1053/rapm.2002.29709.
PubMed 11799511Erickson 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.
PubMed 19472948Feigl 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.
PubMed 32471922
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemidiaphragmatic Paralysis Following Ultrasound-Guided Supraclavicular Brachial Plexus Blockade in Patients Undergoing Upper Limb Surgery
- ClinicalTrials.gov ID
- NCT06491498
- Acronym / sponsor ID
- Soh-Med-24-05-14MS
- Conditions
- Respiratory Depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R in the right upper limb. | – | Diagnostic Test: Supraclavicular Brachial Plexus BlockadeGroup R (30) will receive 15 mL of 0.5% bupivacaine with dexametomidine by dose 1 μg / kg in the right upper limb. |
| Groub L in the left upper limb. | – | Diagnostic Test: Supraclavicular Brachial Plexus BlockadeGroub L (30) will receive 15 mL of 0.5% bupivacaine with dexametomidine by dose 1 μg / kg in the left upper limb. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supraclavicular Brachial Plexus BlockadeHemidiaphragmatic Paralysis Following Ultrasound-Guided Supraclavicular Brachial Plexus Blockade in patients undergoing upper limb surgery | Diagnostic test | Groub L in the left upper limb., Group R in the right upper limb. |
Primary outcome
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 secondary outcomes
Evaluation of post operative pain by visual analog scale
Time frame: 2 hours
Evaluation of oxygen saturation by pulse oximeter
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 14633767Bigeleisen 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.
- Background: PubMed 11799511Rose M, Ness TJ. Hypoxia following interscalene block. Reg Anesth Pain Med. 2002 Jan-Feb;27(1):94-6. doi: 10.1053/rapm.2002.29709.
- Background: PubMed 19472948Erickson 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.
- Background: PubMed 32471922Feigl 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed E Abd-elrahmaan, Prof contact
Magdy M Amin, Professor principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Depression, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abanob Y Mosaad, Resident (01211365548, aym2014.ay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidences of hemi diaphragmatic paralysis following ultrasound-guided supraclavicular plexus blockade (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06491498, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.