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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05072223
Other study ID # PBFS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date March 1, 2022

Study information

Verified date September 2021
Source Henan Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Significant pain after shoulder surgery induce worse experience and may delay recovery of patients undergoing shoulder surgery. Interscalene brachial plexus block (ISB) is a common and rapid-onset procedure for pain control of patients undergoing shoulder surgery. However, the high incidence of adverse events such as hemidiaphragmatic paresis, horner syndrome after interscalene block threatened patients' safety and raised clinicians' concerns on them. Hence, effective analgesia alternatives to interscalene block with less complications are needed. Recently, pericapsular Nerve Group (PENG) Block, a new technology is reported for block of articular branches of the shoulder and well pericapsular spread around the glenohumeral joint. In this study, we assume that PENG Block may offer a noinferior analgesia and less incidence of nerve block related adverse events compared with ISB.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date March 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - ASA I-III - 18 years and older - Shoulder surgery Exclusion Criteria: - Severe pulmonary diseas - Chronic pain disorders - Infection of shouler skin - Pregnant women - Patients allergy to local anesthetics

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pericapsular nerve group block
A new nerve block guided by ultrasound that aims to block articular branches of the shoulder.
Interscalene block
A common and rapid-onset nerve block method guided by ultrasound for pain control of patients undergoing shoulder surgery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Henan Provincial People's Hospital

References & Publications (4)

Küpeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2021 Jun 9. pii: S0104-0014(21)00230-X. doi: 10.1016/j.bjane.2021.05.009. [Epub ahead of print] — View Citation

Lee MG, Shin YJ, You HS, Lim CH, Chang YJ, Shin HJ. A Comparison of Anesthetic Quality Between Interscalene Block and Superior Trunk Block for Arthroscopic Shoulder Surgery: A Randomized Controlled Trial. Pain Physician. 2021 May;24(3):235-242. — View Citation

Yamak Altinpulluk E, Galluccio F, Salazar C, Olea MS, García Simón D, Espinoza K, Teles AS, González-Arnay E, Fajardo Perez M. A novel technique to Axillary Circumflex Nerve Block: Fajardo approach. J Clin Anesth. 2020 Apr 16;64:109826. doi: 10.1016/j.jclinane.2020.109826. [Epub ahead of print] — View Citation

Yamak Altinpulluk E, Teles AS, Galluccio F, Simón DG, Olea MS, Salazar C, Fajardo Perez M. Pericapsular nerve group block for postoperative shoulder pain: A cadaveric radiological evaluation. J Clin Anesth. 2020 Dec;67:110058. doi: 10.1016/j.jclinane.2020.110058. Epub 2020 Sep 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain scores Pain after the shoulder surgery will be measured using an 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable). 3 month
Secondary Adverse events 3 month
See also
  Status Clinical Trial Phase
Completed NCT00497354 - Does a Low Volume Ultrasound-Guided Technique Reduce Common Complications of Interscalene Brachial Plexus Block? Phase 3