Ultrasound-guided PENG Block for Shoulder Surgery

NCT05072223 | Unknown

• 1 other identifier: PBFS
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pain After Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events

  3 month

Study Arms (2)

Group A

EXPERIMENTAL

Procedure: Pericapsular nerve group block

Group B

ACTIVE COMPARATOR

Procedure: Interscalene block

Interventions

Pericapsular nerve group block PROCEDURE

A new nerve block guided by ultrasound that aims to block articular branches of the shoulder.

Group A

Interscalene block PROCEDURE

A common and rapid-onset nerve block method guided by ultrasound for pain control of patients undergoing shoulder surgery.

Group B

Eligibility Criteria

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

You may qualify if:

• ASA I-III
• years and older
• Shoulder surgery

You may not qualify if:

• Severe pulmonary diseas
• Chronic pain disorders
• Infection of shouler skin
• Pregnant women
• Patients allergy to local anesthetics

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Related Publications (4)

• Yamak Altinpulluk E, Teles AS, Galluccio F, Simon 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. No abstract available.

  PMID: 32987232 BACKGROUND

• Yamak Altinpulluk E, Galluccio F, Salazar C, Olea MS, Garcia Simon D, Espinoza K, Teles AS, Gonzalez-Arnay E, Fajardo Perez M. A novel technique to Axillary Circumflex Nerve Block: Fajardo approach. J Clin Anesth. 2020 Sep;64:109826. doi: 10.1016/j.jclinane.2020.109826. Epub 2020 Apr 16. No abstract available.

  PMID: 32305791 BACKGROUND

• Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.

  PMID: 34118263 BACKGROUND

• 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.

  PMID: 33988942 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: October 8, 2021
• Study Start: November 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: October 8, 2021

Record last verified: 2021-09