Orthopedic DisorderNCT05666076
Peng Block or Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Artroscopy ?
A study testing Pericapsular nerve block, Suprascapular nerve block and Bupivacaine Hydrochloride in people with Orthopedic Disorder and Shoulder Pain, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Arthroscopic shoulder surgery, which has been frequently applied in recent years, provides long-term positive clinical results and increases the quality of life after surgery, while it can cause severe pain in the early postoperative period. Postoperative pain management is very important in shoulder arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Orthopedic Disorder, Shoulder Pain, Surgery
- What is being tested?
- Pericapsular nerve block, Suprascapular nerve block and Bupivacaine Hydrochloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 29 Apr 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will have shoulder arthroscopy surgery under general anesthesia
- Ages of 18-75
- ASA I-III
Who cannot join
- Patients with deformity and pathology in the shoulder region
- Patients with known local anesthetic allergy
- Patients with BMI>35
- Patients with alcohol and substance addiction
- Patients with opioid addiction
- Patients who cannot perceive and evaluate pain, such as psychiatric illness, mental retardation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Bakirkoy, 34147
About this study
Official title: Ultrasound-guided Shoulder PENG Block Versus Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Arthroscopy; A Prospective Randomized Controlled Study
Arthroscopic shoulder surgery, which has been frequently applied in recent years, provides long-term positive clinical results and increases the quality of life after surgery, while it can cause severe pain in the early postoperative period. Postoperative pain management is very important in shoulder arthroplasty. Adequate pain control; mental state, nutrition, cost of care, rehabilitation, and patient satisfaction, are of great importance for the patients' recovery and contribute to a successful surgical outcome.
In this study, the investigators aimed to compare the effects of suprascapular nerve block and shoulder pericapsular nerve block, which will be performed preoperatively with ultrasound, on the level of postoperative pain in patients who will undergo shoulder arthroscopy surgery under general anesthesia.
Read the detailed description
As a result of the power analysis the investigators conducted for this study, the minimum sample size was calculated as 32 people for each group, 64 people in total, at the 90% confidence interval.
64 patients who meet the inclusion criteria will be included in our study. The participants will be randomized and divided into 2 groups. Accordingly, the PENG block will be applied to 32 patients, and the suprascapular block will be applied to 32 patients.
- Conditions
- Orthopedic Disorder, Shoulder Pain, Surgery, Analgesia
- Being tested
- Pericapsular nerve block, Suprascapular nerve block, Bupivacaine Hydrochloride
- Keywords
- peng block, suprascapular nerve block, postoperative analgesia
- Medical subject headings
- Musculoskeletal Diseases, Shoulder Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve blockProcedure or surgery
The investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia in shoulder arthroscopy.
Suprascapular nerve blockProcedure or surgery
The investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia in shoulder arthroscopy.
Bupivacaine HydrochlorideDrug
The investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia with bupivacaine hydrochloride
Bupivacaine HydrochlorideDrug
The investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia with bupivacaine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Group PENG | Active comparator | The investigators performed a pericapsular nerve block on that patient group for postoperative analgesia. Receives: Procedure: Pericapsular nerve block; Drug: Bupivacaine Hydrochloride |
| Group SSNB | Active comparator | The investigators performed a suprascapular nerve block on that patient group for postoperative analgesia. Receives: Procedure: Suprascapular nerve block; Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of the study is the patients' postoperative pain scores (NRS)
Numerical rating scale (NRS) at 1, 6, 12, 18, 24, 30, and 36th hours. A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: 36 hours postoperatively
Secondary outcomes (1)
Postoperative 36-hour total tramadol hydrochloride consumption
This will be measured by the PCA device in the 36 hours after
Measured: 36 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start2 Jan 2024
- Primary completion17 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666076
- Sponsor's protocol ID
- 2022-360
- Status last verified
- Jun 2025
- First submitted
- 28 Nov 2022
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: From the date of publication, available data may begin. If requested, the data will be shared with the anesthetists dealing with shoulder blocks.
Publications
Sun C, Zhang X, Ji X, Yu P, Cai X, Yang H. Suprascapular nerve block and axillary nerve block versus interscalene nerve block for arthroscopic shoulder surgery: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2021 Nov 5;100(44):e27661. doi: 10.1097/MD.0000000000027661.
PubMed 34871240Kupeli 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 34118263
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Shoulder PENG Block Versus Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Arthroscopy; A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05666076
- Acronym / sponsor ID
- 2022-360
- Conditions
- Orthopedic Disorder, Shoulder Pain, Surgery, Analgesia
- Keywords
- peng block, suprascapular nerve block, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 27 Dec 2022 (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.
Arthroscopic shoulder surgery, which has been frequently applied in recent years, provides long-term positive clinical results and increases the quality of life after surgery, while it can cause severe pain in the early postoperative period. Postoperative pain management is very important in shoulder arthroplasty. Adequate pain control; mental state, nutrition, cost of care, rehabilitation, and patient satisfaction, are of great importance for the patients' recovery and contribute to a successful surgical outcome.
In this study, the investigators aimed to compare the effects of suprascapular nerve block and shoulder pericapsular nerve block, which will be performed preoperatively with ultrasound, on the level of postoperative pain in patients who will undergo shoulder arthroscopy surgery under general anesthesia.
Detailed description
As a result of the power analysis the investigators conducted for this study, the minimum sample size was calculated as 32 people for each group, 64 people in total, at the 90% confidence interval.
64 patients who meet the inclusion criteria will be included in our study. The participants will be randomized and divided into 2 groups. Accordingly, the PENG block will be applied to 32 patients, and the suprascapular block will be applied to 32 patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PENG | Active comparator | Procedure: Pericapsular nerve block, Drug: Bupivacaine HydrochlorideThe investigators performed a pericapsular nerve block on that patient group for postoperative analgesia. |
| Group SSNB | Active comparator | Procedure: Suprascapular nerve block, Drug: Bupivacaine HydrochlorideThe investigators performed a suprascapular nerve block on that patient group for postoperative analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will have shoulder arthroscopy surgery under general anesthesia
- Ages of 18-75
- ASA I-III
Key exclusion criteria (6 listed)
- Patients with deformity and pathology in the shoulder region
- Patients with known local anesthetic allergy
- Patients with BMI>35
- Patients with alcohol and substance addiction
- Patients with opioid addiction
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 blockThe investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia in shoulder arthroscopy. | Procedure or surgery | Group PENG |
| Suprascapular nerve blockThe investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia in shoulder arthroscopy. | Procedure or surgery | Group SSNB |
| Bupivacaine HydrochlorideThe investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia with bupivacaine hydrochloride | Drug | Group PENG |
| Bupivacaine HydrochlorideThe investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia with bupivacaine hydrochloride | Drug | Group SSNB |
Primary outcome
The primary outcome measure of the study is the patients' postoperative pain scores (NRS)
Time frame: 36 hours postoperatively
Numerical rating scale (NRS) at 1, 6, 12, 18, 24, 30, and 36th hours. A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
1 secondary outcome
Postoperative 36-hour total tramadol hydrochloride consumption
Time frame: 36 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 34871240Sun C, Zhang X, Ji X, Yu P, Cai X, Yang H. Suprascapular nerve block and axillary nerve block versus interscalene nerve block for arthroscopic shoulder surgery: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2021 Nov 5;100(44):e27661. doi: 10.1097/MD.0000000000027661.
- 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.
- Individual participant dataSharing planned: Yes. From the date of publication, available data may begin. If requested, the data will be shared with the anesthetists dealing with shoulder blocks.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve block, Suprascapular nerve block and Bupivacaine Hydrochloride in people with Orthopedic Disorder and Shoulder Pain, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome measure of the study is the patients' postoperative pain scores (NRS) (time frame: 36 hours postoperatively). 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 NCT05666076, which also lists 2 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 11 Jun 2025.