Clinical trial NCT04783064: Neck Anatomy and Phrenic Nerve Palsy After BPB
Official title: Association Between Anatomic Characteristics of Neck and Diaphragmatic Palsy After Brachial Plexus Block: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm; Paralysis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Phrenic nerve palsy
timeFrame: 10 minutes after the end of surgery
Secondary outcomes:
measure: Neck length
timeFrame: Before induction, 1-2 minutes
measure: Neck girth
timeFrame: Before induction, 1-2 minutes
measure: Height
timeFrame: At admission, 1-2 minutes
measure: Weight
timeFrame: At admission, 1-2 minutes
measure: Sex
timeFrame: At admission, 1-2 minutes
measure: The method of brachial plexus block
timeFrame: During brachial plexus block, 10 minutes
measure: The volume (dose) of local anesthetics injected
timeFrame: During brachial plexus block, 10 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.