Pain After Shoulder SurgeryNCT05072223
Ultrasound-guided PENG Block for Shoulder Surgery
A study testing Pericapsular nerve group block and Interscalene block in people with Pain After Shoulder Surgery, run by Henan Provincial People's Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain After Shoulder Surgery
- What is being tested?
- Pericapsular nerve group block and Interscalene block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Mar 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- 18 years and older
- Shoulder surgery
Who cannot join
- Severe pulmonary diseas
- Chronic pain disorders
- Infection of shouler skin
- Pregnant women
- Patients allergy to local anesthetics
About this study
Official title: 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.
- Conditions
- Pain After Shoulder Surgery
- Being tested
- Pericapsular nerve group block, Interscalene block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group blockProcedure or surgery
A new nerve block guided by ultrasound that aims to block articular branches of the shoulder.
Interscalene blockProcedure or surgery
A common and rapid-onset nerve block method guided by ultrasound for pain control of patients undergoing shoulder surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Procedure: Pericapsular nerve group block |
| Group B | Active comparator | Not described Receives: Procedure: Interscalene block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 month
Secondary outcomes (1)
Adverse events
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Mar 2022 (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 Pain After Shoulder SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072223
- Sponsor's protocol ID
- PBFS
- Status last verified
- Sep 2021
- First submitted
- 11 Sep 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32987232Yamak 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.
PubMed 32305791Kupeli 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.
PubMed 34118263Lee 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.
PubMed 33988942
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pericapsular Nerve Group (PENG) Block for Patients Undergoing Shoulder Surgery
- ClinicalTrials.gov ID
- NCT05072223
- Acronym / sponsor ID
- PBFS
- Conditions
- Pain After Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 8 Oct 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Pericapsular nerve group block |
| Group B | Active comparator | Procedure: Interscalene block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III
- 18 years and older
- Shoulder surgery
Key exclusion criteria (5 listed)
- Severe pulmonary diseas
- Chronic pain disorders
- Infection of shouler skin
- Pregnant women
- Patients allergy to local anesthetics
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 |
|---|---|---|
| Pericapsular nerve group blockA new nerve block guided by ultrasound that aims to block articular branches of the shoulder. | Procedure or surgery | Group A |
| Interscalene blockA common and rapid-onset nerve block method guided by ultrasound for pain control of patients undergoing shoulder surgery. | Procedure or surgery | Group B |
Primary outcome
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).
1 secondary outcome
Adverse events
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Background: 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.
- Background: PubMed 32305791Yamak 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.
- Background: PubMed 34118263Kupeli 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.
- Background: PubMed 33988942Lee 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve group block and Interscalene block in people with Pain After Shoulder Surgery, run by Henan Provincial People's 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 8 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain scores (time frame: 3 month). 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 NCT05072223, 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 8 Oct 2021.