Rotator Cuff SyndromeNCT06786013
Effects of Interscalene Block on Visual Clarity in Arthroscopic Surgery
An observational study of Rotator Cuff Syndrome, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
Arthroscopic rotator cuff repair (RCR) has become the predominant technique for managing patients with full-thickness rotator cuff tears. Optimizing visual clarity is crucial for performing shoulder arthroscopy safely, precisely, and successfully. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Syndrome
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2025to 15 Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo arthroscopic rotator cuff repair
Who may be able to join
- Patients able to provide informed consent.
- Patients able to reliably report their symptoms to the research team.
- ASA physical status classification of 1-3.
- Scheduled to undergo arthroscopic rotator cuff repair surgery in the lateral decubitus position.
Who cannot join
- Contraindications to anesthesia.
- Patients under 18 years old.
- Cognitive impairment or communication barriers.
- BMI > 40.
- Weight less than 50 kg or more than 100 kg.
- Psychiatric disorders.
Show all 20Show fewer
- Chronic opioid therapy for pain.
- Severe liver, heart, or kidney failure.
- Hypertension (possibly severe, depending on the study context).
- Use of opioids for any reason.
- Revision shoulder surgery.
- Diaphragmatic paralysis on the opposite side of the planned intervention.
- Concurrent anticoagulation therapy or coagulopathy.
- Skin deformities or infections in the block area.
- Progressive neurological deficits affecting peripheral nerves.
- Allergy to amide-structured local anesthetics.
- ASA physical classification score ≥4.
- Suspected or confirmed pregnancy.
- Breastfeeding mothers.
- Patients who do not consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Interscalene Block Anesthesia on Visual Clarity and Hemodynamic Parameters in Arthroscopic Rotator Cuff Repair: A Prospective, Randomized Study
Arthroscopic rotator cuff repair (RCR) has become the predominant technique for managing patients with full-thickness rotator cuff tears. Optimizing visual clarity is crucial for performing shoulder arthroscopy safely, precisely, and successfully. However, intraoperative bleeding remains the most significant factor impairing visual clarity.
The interscalene brachial plexus block (ISB) technique is widely employed in shoulder joint and upper extremity surgeries. However, ISB may lead to hypertension due to the spread of local anesthetic to adjacent structures, such as the carotid sinus baroreceptors. Hypertension-induced microbleeding can obstruct the surgical field of view.
Read more
Our hypothesis suggests that arthroscopic visual clarity may be compromised in awake patients receiving ISB for anesthesia.
This study aims to compare the effects of interscalene brachial plexus block and general anesthesia on hemodynamic parameters and visual clarity in patients undergoing arthroscopic rotator cuff repair surgery.
Read the detailed description
Our study will be conducted prospectively, and no additional medication or interventional procedure will be administered to the patients. A total of 80 patients, 40 from the general anesthesia group and 40 from the interscalene block anesthesia group, who meet the inclusion criteria, will be included in the study. In both groups, systolic arterial blood pressure (SAB), diastolic arterial blood pressure (DAB), mean arterial blood pressure (MAP), and heart rate (HR) values will be recorded every 5 minutes throughout the operation after the surgical procedure begins. At the end of the operation, visual clarity will be assessed by the same surgeon (M.O) using a Numeric Rating Scale (0 = very poor, 10 = excellent). To detect a 2-point (20%) difference in the NRS score for visual clarity, a total of 37 patients are required with 80% power and a significance level of 0.05. This calculation assumes that such an effect is clinically significant and that the standard deviation is 2.21. Assuming a 10% dropout rate, we calculated that a total of 80 patients would be needed for two groups, with 40 patients per group.
Descriptive statistics, including mean, standard deviation, median, minimum, maximum, frequency, and percentage, will be used to summarize the data. The Kolmogorov-Smirnov test will be employed to assess the distribution of variables. For the comparison of quantitative data, the Independent Samples t-test and Mann-Whitney U test will be utilized. For the comparison of qualitative data, the Chi-Square test will be used. A p-value less than 0.05 will be considered statistically significant.
The cut-off values of quantitative parameters will be determined using ROC analysis.
- Conditions
- Rotator Cuff Syndrome
- Keywords
- interscalene block, visual clarity, Arthroscopic rotator cuff repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene brachial plexus block (ISB) | The group that received ISB for arthroscopic rotator cuff repair anesthesia | |
| General anesthesia group | The group that received general anesthesia for arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual clarity during arthroscopic rotator cuff repair
Visual clarity of the arthroscopic view will be assessed by the same surgeon (MO) using a Numeric Rating Scale (0 = very poor, 10 = excellent).
Measured: 1 day
Secondary outcomes (2)
Hemodynamic parameters
systolic arterial blood pressure (mm Hg), diastolic arterial blood pressure (mm Hg), mean arterial blood pressure (mm Hg), and heart rate (beats per minute) values will be recorded every 5 minutes after IS block and throughout the surgery pressure (mm/Hg), and heart rate (beats per minute) values will be recorded every 5 minutes throughout the operation
Measured: 1 day
Visual analog scale (VAS) pain scores
Pain was evaluated by blinded researcher using visual analog scale (VAS) pain scores
Measured: at 6,12, 18, 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start17 Jan 2025
- Primary completion1 Apr 2025
- Study completion15 Apr 2025
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 Rotator Cuff SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Kilicaslan, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Alper KILICASLAN, Prof, Principal investigator, Konya Necmettin Erbakan Universty Medical Faculty /Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786013
- Sponsor's protocol ID
- 2024/5217
- Status last verified
- Dec 2025
- First submitted
- 8 Jan 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gianesello L, Magherini M, Pavoni V, Horton A, Nella A, Campolo MC. The influence of interscalene block technique on adverse hemodynamic events. J Anesth. 2014 Jun;28(3):407-12. doi: 10.1007/s00540-013-1748-8. Epub 2013 Nov 21.
PubMed 24258467Bildik C, Pehlivanoglu T. Arthroscopic rotator cuff repair performed with intra-articular tranexamic acid: could it provide improved visual clarity and less postoperative pain? A prospective, double-blind, randomized study of 63 patients. J Shoulder Elbow Surg. 2023 Feb;32(2):223-231. doi: 10.1016/j.jse.2022.10.007. Epub 2022 Nov 18.
PubMed 36403924
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interscalene Block Anesthesia on Visual Clarity and Hemodynamic Parameters in Arthroscopic Rotator Cuff Repair: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT06786013
- Acronym / sponsor ID
- 2024/5217
- Conditions
- Rotator Cuff Syndrome
- Keywords
- interscalene block, visual clarity, Arthroscopic rotator cuff repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 22 Jan 2025 (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 rotator cuff repair (RCR) has become the predominant technique for managing patients with full-thickness rotator cuff tears. Optimizing visual clarity is crucial for performing shoulder arthroscopy safely, precisely, and successfully. However, intraoperative bleeding remains the most significant factor impairing visual clarity.
The interscalene brachial plexus block (ISB) technique is widely employed in shoulder joint and upper extremity surgeries. However, ISB may lead to hypertension due to the spread of local anesthetic to adjacent structures, such as the carotid sinus baroreceptors. Hypertension-induced microbleeding can obstruct the surgical field of view.
Our hypothesis suggests that arthroscopic visual clarity may be compromised in awake patients receiving ISB for anesthesia.
This study aims to compare the effects of interscalene brachial plexus block and general anesthesia on hemodynamic parameters and visual clarity in patients undergoing arthroscopic rotator cuff repair surgery.
Detailed description
Our study will be conducted prospectively, and no additional medication or interventional procedure will be administered to the patients. A total of 80 patients, 40 from the general anesthesia group and 40 from the interscalene block anesthesia group, who meet the inclusion criteria, will be included in the study. In both groups, systolic arterial blood pressure (SAB), diastolic arterial blood pressure (DAB), mean arterial blood pressure (MAP), and heart rate (HR) values will be recorded every 5 minutes throughout the operation after the surgical procedure begins. At the end of the operation, visual clarity will be assessed by the same surgeon (M.O) using a Numeric Rating Scale (0 = very poor, 10 = excellent). To detect a 2-point (20%) difference in the NRS score for visual clarity, a total of 37 patients are required with 80% power and a significance level of 0.05. This calculation assumes that such an effect is clinically significant and that the standard deviation is 2.21. Assuming a 10% dropout rate, we calculated that a total of 80 patients would be needed for two groups, with 40 patients per group.
Descriptive statistics, including mean, standard deviation, median, minimum, maximum, frequency, and percentage, will be used to summarize the data. The Kolmogorov-Smirnov test will be employed to assess the distribution of variables. For the comparison of quantitative data, the Independent Samples t-test and Mann-Whitney U test will be utilized. For the comparison of qualitative data, the Chi-Square test will be used. A p-value less than 0.05 will be considered statistically significant.
The cut-off values of quantitative parameters will be determined using ROC analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene brachial plexus block (ISB) | – | –The group that received ISB for arthroscopic rotator cuff repair anesthesia |
| General anesthesia group | – | –The group that received general anesthesia for arthroscopic rotator cuff repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo arthroscopic rotator cuff repair
Key inclusion criteria (4 listed)
- Patients able to provide informed consent.
- Patients able to reliably report their symptoms to the research team.
- ASA physical status classification of 1-3.
- Scheduled to undergo arthroscopic rotator cuff repair surgery in the lateral decubitus position.
Key exclusion criteria (20 listed)
- Contraindications to anesthesia.
- Patients under 18 years old.
- Cognitive impairment or communication barriers.
- BMI > 40.
- Weight less than 50 kg or more than 100 kg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual clarity during arthroscopic rotator cuff repair
Time frame: 1 day
Visual clarity of the arthroscopic view will be assessed by the same surgeon (MO) using a Numeric Rating Scale (0 = very poor, 10 = excellent).
2 secondary outcomes
Hemodynamic parameters
Time frame: 1 day
Visual analog scale (VAS) pain scores
Time frame: at 6,12, 18, 24 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 23 Dec 2025.
- Results publication: PubMed 24258467Gianesello L, Magherini M, Pavoni V, Horton A, Nella A, Campolo MC. The influence of interscalene block technique on adverse hemodynamic events. J Anesth. 2014 Jun;28(3):407-12. doi: 10.1007/s00540-013-1748-8. Epub 2013 Nov 21.
- Results publication: PubMed 36403924Bildik C, Pehlivanoglu T. Arthroscopic rotator cuff repair performed with intra-articular tranexamic acid: could it provide improved visual clarity and less postoperative pain? A prospective, double-blind, randomized study of 63 patients. J Shoulder Elbow Surg. 2023 Feb;32(2):223-231. doi: 10.1016/j.jse.2022.10.007. Epub 2022 Nov 18.
- Individual participant dataSharing planned: No
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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.
Alper KILICASLAN, Prof principal investigator
Konya Necmettin Erbakan Universty Medical Faculty /Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Syndrome, run by Konya Necmettin Erbakan Üniversitesi 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 4 inclusion and 20 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 23 Dec 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?
Visual clarity during arthroscopic rotator cuff repair (time frame: 1 day). 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 NCT06786013, 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 23 Dec 2025.