Neck Anatomy and Phrenic Nerve Palsy After BPB

NCT04783064 | Completed DMC

• 1 other identifier: H-2102-133-1199
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diaphragm; Paralysis

Outcome Measures

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.

  10 minutes after the end of surgery

Secondary Outcomes (7)

• Neck length

  Before induction, 1-2 minutes

• Neck girth

  Before induction, 1-2 minutes

• Height

  At admission, 1-2 minutes

• Weight

  At admission, 1-2 minutes

• Sex

  At admission, 1-2 minutes

Interventions

Interscalene brachial plexus block PROCEDURE

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

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (8)

• 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.

  PMID: 2006740 BACKGROUND

• 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.

  PMID: 31283740 BACKGROUND

• 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.

  PMID: 21858614 BACKGROUND

• 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.

  PMID: 31490292 BACKGROUND

• 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.

  PMID: 30640655 BACKGROUND

• 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.

  PMID: 21461062 BACKGROUND

• 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.

  PMID: 33217801 BACKGROUND

• 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.

  PMID: 28514241 BACKGROUND

MeSH Terms

Conditions

Respiratory Paralysis

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin-Tae Kim, M.D, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 5, 2021
• Study Start: March 17, 2021
• Primary Completion: October 26, 2022
• Study Completion: March 21, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)