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CompletedNCT04783064Updated Aug 24, 2023

Neck Anatomy and Phrenic Nerve Palsy After BPB

An observational study in Diaphragm; Paralysis, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-24.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
19 Years to 80 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Diaphragm; Paralysis

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03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 199 observational studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients over 19 years undergoing shoulder arthroscopic surgery for a rotator cuff tear repair under general anesthesia

Inclusion criteria

  • Adult patients over 19 years undergoing shoulder arthroscopic surgery for a rotator cuff tear repair under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • ProcedureInterscalene brachial plexus block

    Interscalene brachial plexus block is performed at ipsilateral side of the affected shoulder.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 minutes after the end of surgery

Secondary outcomes

  1. 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.

    Time frame: Before induction, 1-2 minutes

  2. 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.

    Time frame: Before induction, 1-2 minutes

  3. Height

    Height (cm)

    Time frame: At admission, 1-2 minutes

  4. Weight

    Weight (kg)

    Time frame: At admission, 1-2 minutes

  5. Sex

    Sex

    Time frame: At admission, 1-2 minutes

  6. 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)

    Time frame: During brachial plexus block, 10 minutes

  7. The volume (dose) of local anesthetics injected

    The volume (dose) of local anesthetics injected

    Time frame: During brachial plexus block, 10 minutes

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
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References and documents

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 2006740 ↗
  • Kim 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 31283740 ↗
  • Lee 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 21858614 ↗
  • Kang 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 31490292 ↗
  • Bao 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 30640655 ↗
  • Choi 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 21461062 ↗
  • Zhang 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 33217801 ↗
  • El-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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04783064
Lead sponsor
Seoul National University Hospital
Responsible party
Jin-Tae Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Mar 5, 2021
Start date
Mar 17, 2021
Primary completion
Oct 26, 2022
Completion
Mar 21, 2023
Last update
Aug 24, 2023

Study contacts

Jin-Tae Kim, M.D, Ph.D
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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