Diaphragm; ParalysisNCT04783064
Neck Anatomy and Phrenic Nerve Palsy After BPB
An observational study of Diaphragm; Paralysis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to determine the association between the anatomical characteristics of neck and postoperative diaphragmatic paralysis in patients undergoing interscalene brachial plexus block before shoulder arthroscopic surgery. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Diaphragm; Paralysis
- What is being tested?
- Interscalene brachial plexus block
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Mar 2021to 21 Mar 2023
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients over 19 years undergoing shoulder arthroscopic surgery for a rotator cuff tear repair under general anesthesia
Who may be able to join
- Adult patients over 19 years undergoing shoulder arthroscopic surgery for a rotator cuff tear repair under general anesthesia
Who cannot join
- Patients who refused to participate in the trial
- Patients with respiratory diseases such as asthma and chronic obstructive pulmonary disease
- Patients with neurological abnormalities of the upper limb
- Patients with a history of surgery around the neck on the ipsilateral side of the surgery site, radiation treatment history, etc.
- Patients with a history of allergy or hypersensitivity reactions to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Anatomic Characteristics of Neck and Diaphragmatic Palsy After Brachial Plexus Block: A Prospective Observational Study
The purpose of this study was to determine the association between the anatomical characteristics of neck and postoperative diaphragmatic paralysis in patients undergoing interscalene brachial plexus block before shoulder arthroscopic surgery.
Read the detailed description
The purpose of this study was to determine the association between the anatomical characteristics of neck and postoperative diaphragmatic paralysis in patients undergoing interscalene brachial plexus block before shoulder arthroscopic surgery. In addition, we want to identify risk factors for diaphragmatic paralysis after brachial plexus block. Through this study, we can find the basis for predicting the possibility of diaphragmatic paralysis after brachial plexus block according to the patient's anatomical characteristics and procedural factors.
- Conditions
- Diaphragm; Paralysis
- Being tested
- Interscalene brachial plexus block
- Medical subject headings
- Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockProcedure or surgery
Interscalene brachial plexus block is performed at ipsilateral side of the affected shoulder.
What is being measured
The primary outcome is the main question the study is designed to answer.
Phrenic nerve palsy
Ultrasound is used to check the movement of the diaphragm on the operation side. The movement of the diaphragm is measured in centimeters when checked with M-mode in a forceful sniffing state.
Measured: 10 minutes after the end of surgery
Secondary outcomes (7)
Neck length
The neck length is measured by drawing a straight line from the mandible angle on the side to the middle point of the clavicle with a tape measure.
Measured: Before induction, 1-2 minutes
Neck girth
The neck circumference length is measured by a tape ruler over the upper plane of the spinous process of the 7th cervical spine at the back and the lower plane of the thyroid cartilage at the front side in the patient's sitting position.
Measured: Before induction, 1-2 minutes
Height
Height (cm)
Measured: At admission, 1-2 minutes
Weight
Weight (kg)
Measured: At admission, 1-2 minutes
Sex
Sex
Measured: At admission, 1-2 minutes
The method of brachial plexus block
Specific location where the brachial plexus block was performed (Specific location of needle tip where local anesthetic is injected)
Measured: During brachial plexus block, 10 minutes
The volume (dose) of local anesthetics injected
The volume (dose) of local anesthetics injected
Measured: During brachial plexus block, 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start17 Mar 2021
- Primary completion26 Oct 2022
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diaphragm; ParalysisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, M.D, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783064
- Sponsor's protocol ID
- H-2102-133-1199
- Status last verified
- Aug 2023
- First submitted
- 25 Feb 2021
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PubMed 2006740Kim DH, Lin Y, Beathe JC, Liu J, Oxendine JA, Haskins SC, Ho MC, Wetmore DS, Allen AA, Wilson L, Garnett C, Memtsoudis SG. Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial. Anesthesiology. 2019 Sep;131(3):521-533. doi: 10.1097/ALN.0000000000002841.
PubMed 31283740Lee JH, Cho SH, Kim SH, Chae WS, Jin HC, Lee JS, Kim YI. Ropivacaine for ultrasound-guided interscalene block: 5 mL provides similar analgesia but less phrenic nerve paralysis than 10 mL. Can J Anaesth. 2011 Nov;58(11):1001-6. doi: 10.1007/s12630-011-9568-5. Epub 2011 Aug 20.
PubMed 21858614Kang R, Jeong JS, Chin KJ, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Ko JS. Superior Trunk Block Provides Noninferior Analgesia Compared with Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery. Anesthesiology. 2019 Dec;131(6):1316-1326. doi: 10.1097/ALN.0000000000002919.
PubMed 31490292Bao X, Huang J, Feng H, Qian Y, Wang Y, Zhang Q, Hu H, Wang X. Effect of local anesthetic volume (20 mL vs 30 mL ropivacaine) on electromyography of the diaphragm and pulmonary function after ultrasound-guided supraclavicular brachial plexus block: a randomized controlled trial. Reg Anesth Pain Med. 2019 Jan;44(1):69-75. doi: 10.1136/rapm-2018-000014.
PubMed 30640655Choi JH, Miyazaki S, Okawa M, Kim EJ, Ryu JJ, Lee JB, Shin C, Lee SH. Clinical implications of mandible and neck measurements in non-obese asian snorers: ansan city general population-based study. Clin Exp Otorhinolaryngol. 2011 Mar;4(1):40-3. doi: 10.3342/ceo.2011.4.1.40. Epub 2011 Mar 17.
PubMed 21461062Zhang Y, Wu H, Xu Y, Qin H, Lan C, Wang W. The correlation between neck circumference and risk factors in patients with hypertension: What matters. Medicine (Baltimore). 2020 Nov 20;99(47):e22998. doi: 10.1097/MD.0000000000022998.
PubMed 33217801El-Boghdadly K, Chin KJ, Chan VWS. Phrenic Nerve Palsy and Regional Anesthesia for Shoulder Surgery: Anatomical, Physiologic, and Clinical Considerations. Anesthesiology. 2017 Jul;127(1):173-191. doi: 10.1097/ALN.0000000000001668.
PubMed 28514241
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Anatomic Characteristics of Neck and Diaphragmatic Palsy After Brachial Plexus Block: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04783064
- Acronym / sponsor ID
- H-2102-133-1199
- Conditions
- Diaphragm; Paralysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 5 Mar 2021 (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 purpose of this study was to determine the association between the anatomical characteristics of neck and postoperative diaphragmatic paralysis in patients undergoing interscalene brachial plexus block before shoulder arthroscopic surgery.
Detailed description
The purpose of this study was to determine the association between the anatomical characteristics of neck and postoperative diaphragmatic paralysis in patients undergoing interscalene brachial plexus block before shoulder arthroscopic surgery. In addition, we want to identify risk factors for diaphragmatic paralysis after brachial plexus block. Through this study, we can find the basis for predicting the possibility of diaphragmatic paralysis after brachial plexus block according to the patient's anatomical characteristics and procedural factors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients over 19 years undergoing shoulder arthroscopic surgery for a rotator cuff tear repair under general anesthesia
Key inclusion criteria (1 listed)
- Adult patients over 19 years undergoing shoulder arthroscopic surgery for a rotator cuff tear repair under general anesthesia
Key exclusion criteria (5 listed)
- Patients who refused to participate in the trial
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 |
|---|---|---|
| Interscalene brachial plexus blockInterscalene brachial plexus block is performed at ipsilateral side of the affected shoulder. | Procedure or surgery | – |
Primary outcome
Phrenic nerve palsy
Time frame: 10 minutes after the end of surgery
Ultrasound is used to check the movement of the diaphragm on the operation side. The movement of the diaphragm is measured in centimeters when checked with M-mode in a forceful sniffing state.
7 secondary outcomes
Neck length
Time frame: Before induction, 1-2 minutes
Neck girth
Time frame: Before induction, 1-2 minutes
Height
Time frame: At admission, 1-2 minutes
Weight
Time frame: At admission, 1-2 minutes
Sex
Time frame: At admission, 1-2 minutes
The method of brachial plexus block
Time frame: During brachial plexus block, 10 minutes
The volume (dose) of local anesthetics injected
Time frame: During brachial plexus block, 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Background: PubMed 2006740Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
- Background: PubMed 31283740Kim DH, Lin Y, Beathe JC, Liu J, Oxendine JA, Haskins SC, Ho MC, Wetmore DS, Allen AA, Wilson L, Garnett C, Memtsoudis SG. Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial. Anesthesiology. 2019 Sep;131(3):521-533. doi: 10.1097/ALN.0000000000002841.
- Background: PubMed 21858614Lee JH, Cho SH, Kim SH, Chae WS, Jin HC, Lee JS, Kim YI. Ropivacaine for ultrasound-guided interscalene block: 5 mL provides similar analgesia but less phrenic nerve paralysis than 10 mL. Can J Anaesth. 2011 Nov;58(11):1001-6. doi: 10.1007/s12630-011-9568-5. Epub 2011 Aug 20.
- Background: PubMed 31490292Kang R, Jeong JS, Chin KJ, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Ko JS. Superior Trunk Block Provides Noninferior Analgesia Compared with Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery. Anesthesiology. 2019 Dec;131(6):1316-1326. doi: 10.1097/ALN.0000000000002919.
- Background: PubMed 30640655Bao X, Huang J, Feng H, Qian Y, Wang Y, Zhang Q, Hu H, Wang X. Effect of local anesthetic volume (20 mL vs 30 mL ropivacaine) on electromyography of the diaphragm and pulmonary function after ultrasound-guided supraclavicular brachial plexus block: a randomized controlled trial. Reg Anesth Pain Med. 2019 Jan;44(1):69-75. doi: 10.1136/rapm-2018-000014.
- Background: PubMed 21461062Choi JH, Miyazaki S, Okawa M, Kim EJ, Ryu JJ, Lee JB, Shin C, Lee SH. Clinical implications of mandible and neck measurements in non-obese asian snorers: ansan city general population-based study. Clin Exp Otorhinolaryngol. 2011 Mar;4(1):40-3. doi: 10.3342/ceo.2011.4.1.40. Epub 2011 Mar 17.
- Background: PubMed 33217801Zhang Y, Wu H, Xu Y, Qin H, Lan C, Wang W. The correlation between neck circumference and risk factors in patients with hypertension: What matters. Medicine (Baltimore). 2020 Nov 20;99(47):e22998. doi: 10.1097/MD.0000000000022998.
- Background: PubMed 28514241El-Boghdadly K, Chin KJ, Chan VWS. Phrenic Nerve Palsy and Regional Anesthesia for Shoulder Surgery: Anatomical, Physiologic, and Clinical Considerations. Anesthesiology. 2017 Jul;127(1):173-191. doi: 10.1097/ALN.0000000000001668.
- Individual participant dataSharing planned: No
Related trials for Diaphragm; Paralysis
Not yet recruiting
Impact of High Thoracic Paravertebral Block on Diaphragmatic Function: a Prospective Study
Breast Cancer Surgery, Breast Cancer Surgery Pain
Recruiting
Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine
Diaphragmatic Function, Metacarpal Fracture
Not yet recruitingPhase 4
Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery
Hemidiaphragmatic Paralysis, Postoperative Pain
Recruiting
Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
Atrial Fibrillation
Enrolling by invitation
Transcutaneous Diaphragmatic Electrical Stimulation and Pulmonary Function in Non-Ambulatory Cerebral Palsy
Cerebral Palsy
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.
Jin-Tae Kim, M.D, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diaphragm; Paralysis, run by Seoul National University Hospital at 1 site in South Korea.
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 5 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: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phrenic nerve palsy (time frame: 10 minutes after the end of surgery). 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 NCT04783064, which also lists 8 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 24 Aug 2023.