- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04718090
Comparison of Interscalene and Pericapsular Nerve Group (PENG) Block in Shoulder Surgery
January 20, 2021 updated by: Merve Yazici Kara, Kocaeli Derince Education and Research Hospital
Comparison of Postoperative Analgesic Consumption and Pain in Shoulder Surgery Patients Undergoing Interscalene and Pericapsular Nerve Group (PENG) Blocks
Early postoperative pain after shoulder surgery is a major concern and distress for patients and orthopedic surgeons.
Adequate pain control; It is vital for all aspects of patient recovery, including mental state, nutrition, cost of care period, rehabilitation, patient satisfaction, and overall post-surgery outcomes.Single analgesic regimens are not always effective in controlling moderate to severe postoperative pain.Therefore, multimodal pain management is preferred and is currently recommended for early postoperative pain control.Regional anesthesia is preferred in shoulder surgery as an effective way to provide anesthesia and postoperative analgesia.To ensure adequate postoperative pain control, nerve supply to the synovium, capsule, joint surfaces, ligaments, periosteum and shoulder muscles must be blocked.Interscalene blocks are well studied and established means of providing analgesia following shoulder surgery and are considered the gold standard mode of regional anesthesia.Pericapsular nerve group block is a new block that provides a pericapsular distribution with local anesthetic infiltration around the glenohumeral joint and provides analgesia without motor blockage by reaching the sensory nerve branches of the glenohumeral joint.The aim of this study was to compare the results between interscalene block and pericapsular nerve group block in patients undergoing shoulder surgery.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years and over
- American Society of Anesthesiologists (ASA) 1 and 2
- shoulder surgery
Exclusion Criteria:
- under 18 years old
- American Society of Anesthesiologists (ASA) 3 and above
- who are allergic to local anesthetics
- patients with infection at the injection site
- pregnant women
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: interscalene block
|
Pericapsular nerve group block in shoulder surgery.
|
|
ACTIVE_COMPARATOR: PENG block
|
Pericapsular nerve group block in shoulder surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 5 months
|
Visual Analogue Scale
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
- Patel MS, Abboud JA, Sethi PM. Perioperative pain management for shoulder surgery: evolving techniques. J Shoulder Elbow Surg. 2020 Nov;29(11):e416-e433. doi: 10.1016/j.jse.2020.04.049. Epub 2020 Jun 9.
- Sripada R, Bowens C Jr. Regional anesthesia procedures for shoulder and upper arm surgery upper extremity update--2005 to present. Int Anesthesiol Clin. 2012 Winter;50(1):26-46. doi: 10.1097/AIA.0b013e31821a0284.
- 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.
- Tran J, Peng PWH, Agur AMR. Anatomical study of the innervation of glenohumeral and acromioclavicular joint capsules: implications for image-guided intervention. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100152. doi: 10.1136/rapm-2018-100152. Online ahead of print.
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)
February 1, 2021
Primary Completion (ANTICIPATED)
June 30, 2021
Study Completion (ANTICIPATED)
July 31, 2021
Study Registration Dates
First Submitted
January 17, 2021
First Submitted That Met QC Criteria
January 20, 2021
First Posted (ACTUAL)
January 22, 2021
Study Record Updates
Last Update Posted (ACTUAL)
January 22, 2021
Last Update Submitted That Met QC Criteria
January 20, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- MYaziciKara-1
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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