Ultrasound-guided PENG Block for Shoulder Surgery

October 5, 2021 updated by: Henan Provincial People's Hospital

Efficacy and Safety of Pericapsular Nerve Group (PENG) Block for Patients Undergoing Shoulder Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Procedure: Pericapsular nerve group block
A new nerve block guided by ultrasound that aims to block articular branches of the shoulder.
Active Comparator: Group B
Procedure: Interscalene block
A common and rapid-onset nerve block method guided by ultrasound for pain control of patients undergoing shoulder surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores
Time Frame: 3 month
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 Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

September 11, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PBFS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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