Visual Analogue ScoreNCT04718090
Comparison of Interscalene and Pericapsular Nerve Group (PENG) Block in Shoulder Surgery
A study testing PENG Block in people with Visual Analogue Score, run by Kocaeli Derince Education and Research Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Analogue Score
- What is being tested?
- PENG Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over
- American Society of Anesthesiologists (ASA) 1 and 2
- shoulder surgery
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Visual Analogue Score
- Being tested
- PENG Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockProcedure or surgery
Pericapsular nerve group block in shoulder surgery.
| Study group | Role | What they receive |
|---|---|---|
| interscalene block | Active comparator | Not described Receives: Procedure: PENG Block |
| PENG block | Active comparator | Not described Receives: Procedure: PENG Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Visual Analogue Scale
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Visual Analogue ScoreStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mustafa Kemal University
- Responsible party
- Principal investigator, Merve Yazici Kara, Kocaeli Derince Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718090
- Sponsor's protocol ID
- MYaziciKara-1
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32844751Sripada 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.
PubMed 22227421Yamak 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.
PubMed 32987232Tran 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.
PubMed 30635516
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Consumption and Pain in Shoulder Surgery Patients Undergoing Interscalene and Pericapsular Nerve Group (PENG) Blocks
- ClinicalTrials.gov ID
- NCT04718090
- Acronym / sponsor ID
- MYaziciKara-1
- Conditions
- Visual Analogue Score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Collaborators
- Mustafa Kemal University
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interscalene block | Active comparator | Procedure: PENG Block |
| PENG block | Active comparator | Procedure: PENG Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and over
- American Society of Anesthesiologists (ASA) 1 and 2
- shoulder surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENG BlockPericapsular nerve group block in shoulder surgery. | Procedure or surgery | PENG block, interscalene block |
Primary outcome
Visual Analogue Scale
Time frame: 5 months
Visual Analogue Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Results publication: PubMed 32844751Patel 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.
- Results publication: PubMed 22227421Sripada 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.
- Results publication: PubMed 32987232Yamak 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.
- Results publication: PubMed 30635516Tran 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing PENG Block in people with Visual Analogue Score, run by Kocaeli Derince Education and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Yazici Kara, M.D. (+90 533 686 0156, merreset@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04718090, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.