Shoulder ArthroscopyNCT07343414
Effect of Anesthesia Technique on Surgical View in Shoulder Arthroscopy
An observational study of Shoulder Arthroscopy and Interscalene Nerve Block, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluates the effect of the anesthesia method (general anesthesia versus regional anesthesia [interscalene nerve block/superficial cervical block] with sedation) on the operating clarity of the surgical view and the surgeon's satisfaction during elective shoulder arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Arthroscopy, Interscalene Nerve Block, Surgical View Quality
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population consists of adult patients (aged 18 to 75 years) who are scheduled to undergo elective shoulder arthroscopy at the Sabuncuoğlu Şerefeddin Training and Research Hospital. These participants are recruited from the patient pool presenting to the Orthopedics and Traumatology clinic for surgical treatment of shoulder pathologies (rotator cuff tears or impingement). Participants include individuals with an ASA physical status of I, II, or III who are capable of providing informed consent .
Who may be able to join
- Volunteers aged 18 to 75 years.
- Patients scheduled for elective shoulder arthroscopy.
- Patients with an ASA (American Society of Anesthesiologists) physical status score of I, II, or III.
- Patients capable of providing informed consent.
Who cannot join
- Previous surgical procedure performed on the same shoulder.
- Presence of medical contraindications that could affect the choice of anesthesia (coagulopathy, active infection, severe pulmonary diseases)
- Known allergy to local anesthetics or general anesthesia agents
- History of opioid dependence or chronic pain syndrome
- Presence of neurological disorders, particularly those involving the brachial plexus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Amasya University Sabuncuoglu Serefeddin Educational and Research Hospital
Amasya
Harun Tolga Duran, M.D., +90 537 985 65 99, htd0561@gmail.com
About this study
Official title: Impact of Anesthesia Method on Surgical View and Surgeon Satisfaction During Shoulder Arthroscopy: A Prospective Observational Study
This prospective observational study evaluates the effect of the anesthesia method (general anesthesia versus regional anesthesia [interscalene nerve block/superficial cervical block] with sedation) on the operating clarity of the surgical view and the surgeon's satisfaction during elective shoulder arthroscopy. The study investigates how these different anesthesia techniques influence intraoperative conditions, specifically bleeding amounts and the visibility of the surgical field, which are critical for the success of this minimally invasive procedure. Additionally, the research will monitor patient-centered outcomes, including postoperative pain levels, recovery time, and potential side effects such as nausea or vomiting, to determine which anesthesia strategy provides the optimal balance of surgical efficiency and patient comfort.
Read the detailed description
Shoulder arthroscopy is a minimally invasive surgical procedure where the clarity of the surgeon's visual field is critical for technical success and operative efficiency. The quality of the intraoperative view is heavily influenced by perioperative variables, particularly intraoperative bleeding and hemodynamic stability. Consequently, the anesthetic management strategy-whether General Anesthesia (GA) or Regional Anesthesia (RA) [interscalene nerve block/superficial cervical block] combined with sedation-may significantly alter these conditions. This study aims to prospectively evaluate and compare how these two distinct anesthesia methods impact the clarity of the surgical field, and the operating surgeon's satisfaction.
This is a prospective, observational cohort study will conducted at the Sabuncuoğlu Serefeddin Training and Research Hospital. The study utilizes a naturalistic, non-randomized design. There is no interference with the choice of anesthesia; group assignment is determined solely by routine clinical decision-making and patient preference during the preoperative assessment. Patients are recruited and observationally assigned to one of two cohorts based on the technique administered:
- General Anesthesia Group: Patients who elect or are clinically selected to receive general anesthesia.
- Regional Anesthesia Group: Patients who elect or are clinically selected to receive an interscalene nerve block/superficial cervical block combined with sedation.
Intraoperative physiological variables, including heart rate, systolic and diastolic blood pressure, oxygen saturation, and respiratory rate, will be continuously monitored throughout the procedure. The study will also record the feasibility of implementing controlled hypotension and analyze its correlation with intraoperative bleeding amounts. To provide a holistic comparison between anesthesia methods, the study will track postoperative recovery metrics, including the total duration of surgery and anesthesia. Additionally, postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 1, 2, 4, 8, 16, and 24 hours post-procedure. The incidence of opioid-related side effects, such as nausea and vomiting, will be monitored and recorded during the postoperative period .
Primary Assessment:
- Surgical View Evaluation: The clarity of the surgical field and the extent to which bleeding obscures visualization are evaluated using a 5-point Likert scale (1 = Poor/No Visualization: Severe bleeding that completely obscures the field; surgery is extremely difficult or impossible without constant suction/lavage; 2 = Fair Visualization: Significant bleeding obscuring the field; frequent suction/lavage is required to proceed; 3 = Moderate Visualization: Moderate bleeding; the anatomy is visible, but occasional suction/lavage is needed to maintain a clear view; 4 = Good Visualization: Mild bleeding; the surgical field is clear with only rare need for suction/lavage; 5 = Excellent/Crystal Clear Visualization: No significant bleeding; the surgical field is perfectly clear throughout the procedure.)
Sample Size: Based on a preliminary analysis conducted at our center, a distinct difference in the primary outcome (Surgical view evaluation) was observed between the two groups (RA: 3.1 ± 1.2 vs. GA: 4.0 ± 1.5). To detect this difference with a Power (1-beta) of 0.80 and an alpha error of 0.05, a sample size of 37 patients per group is required. Accounting for a 10% dropout rate, the study will enroll a total of 82 patients (41 in the GA group and 41 in the RA group).
- Conditions
- Shoulder Arthroscopy, Interscalene Nerve Block, Surgical View Quality, Surgeon Satisfaction
- Keywords
- Shoulder Arthroscopy, Surgeon Satisfaction, Surgical View Quality, Interscalene Nerve Block, 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 |
|---|---|---|
| General Anesthesia Group | Patients undergoing elective shoulder arthroscopy who receive general anesthesia as determined by routine clinical practice and patient preference. | |
| Regional Anesthesia Group | Patients undergoing elective shoulder arthroscopy who receive regional anesthesia [interscalene nerve block/superficial cervical block] combined with sedation as determined by routine clinical practice and patient preference. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical View Clarity Score
The clarity of the surgical field and the extent to which bleeding obscures visualization are evaluated by the surgeon using a 5-point Likert scale. The scale ranges from 1 (Poor/No Visualization) to 5 (Excellent/Crystal Clear Visualization).
Measured: Intraoperative (assessed immediately upon completion of wound closure)
Secondary outcomes (8)
Surgeon Satisfaction Score
The operating surgeon's overall satisfaction with the procedure and the conditions provided by the anesthesia is assessed using a 5-point Likert scale. The scale is defined as: 1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, 5 = Very Satisfied.
Measured: Intraoperative (assessed immediately upon completion of wound closure)
Intraarticular Bleeding Severity
The operating surgeon's subjective assessment of the amount of bleeding within the joint during the arthroscopy. This is evaluated using a categorical scale:
- Good: Minimal bleeding that does not interfere with the procedure.
- Moderate: Bleeding is present but manageable; does not significantly hinder the procedure.
- Poor: Significant bleeding that obscures the surgical field and complicates the procedure.
Measured: Intraoperative
Feasibility of Controlled Hypotension
Binary assessment of whether controlled hypotension (systolic blood pressure reduction to reduce bleeding) was successfully applied and maintained during the surgery (Yes/No).
Measured: Intraoperative
Duration of Surgery
The time in minutes measured from the start of the incision to the completion of wound closure.
Measured: Intraoperative
Duration of Anesthesia
The total time in minutes from the induction of anesthesia to the cessation of anesthetic effects/emergence.
Measured: Intraoperative
Postoperative Pain Score (NRS)
Assessment of patient pain intensity using the Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst pain imaginable."
Measured: Postoperative hours 1, 2, 4, 8, 16, and 24
Incidence of Opioid-Related Side Effects
The occurrence of specific side effects associated with opioid use, including nausea, vomiting, and pruritus (itching).
Measured: Postoperative 24 hours
Patient Satisfaction Score
The patient's self-reported level of satisfaction with the perioperative process and their comfort level. This is assessed using a 5-point Likert scale (1 = Very Dissatisfied; 2 = Dissatisfied; 3 = Neutral; 4 = Satisfied; 5 = Very Satisfied)
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun Tolga Duran, Amasya University
- Investigators
- Ahmet Salih Tüzen, M.D., Principal investigator, Izmir Katip Celebi University Atatürk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343414
- Sponsor's protocol ID
- 2025000139-3
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anesthesia Method on Surgical View and Surgeon Satisfaction During Shoulder Arthroscopy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07343414
- Acronym / sponsor ID
- 2025000139-3
- Conditions
- Shoulder Arthroscopy, Interscalene Nerve Block, Surgical View Quality, Surgeon Satisfaction
- Keywords
- Shoulder Arthroscopy, Surgeon Satisfaction, Surgical View Quality, Interscalene Nerve Block, Rotator Cuff Repair
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 15 Jan 2026 (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.
This prospective observational study evaluates the effect of the anesthesia method (general anesthesia versus regional anesthesia [interscalene nerve block/superficial cervical block] with sedation) on the operating clarity of the surgical view and the surgeon's satisfaction during elective shoulder arthroscopy. The study investigates how these different anesthesia techniques influence intraoperative conditions, specifically bleeding amounts and the visibility of the surgical field, which are critical for the success of this minimally invasive procedure. Additionally, the research will monitor patient-centered outcomes, including postoperative pain levels, recovery time, and potential side effects such as nausea or vomiting, to determine which anesthesia strategy provides the optimal balance of surgical efficiency and patient comfort.
Detailed description
Shoulder arthroscopy is a minimally invasive surgical procedure where the clarity of the surgeon's visual field is critical for technical success and operative efficiency. The quality of the intraoperative view is heavily influenced by perioperative variables, particularly intraoperative bleeding and hemodynamic stability. Consequently, the anesthetic management strategy-whether General Anesthesia (GA) or Regional Anesthesia (RA) [interscalene nerve block/superficial cervical block] combined with sedation-may significantly alter these conditions. This study aims to prospectively evaluate and compare how these two distinct anesthesia methods impact the clarity of the surgical field, and the operating surgeon's satisfaction.
This is a prospective, observational cohort study will conducted at the Sabuncuoğlu Serefeddin Training and Research Hospital. The study utilizes a naturalistic, non-randomized design. There is no interference with the choice of anesthesia; group assignment is determined solely by routine clinical decision-making and patient preference during the preoperative assessment. Patients are recruited and observationally assigned to one of two cohorts based on the technique administered:
- General Anesthesia Group: Patients who elect or are clinically selected to receive general anesthesia.
- Regional Anesthesia Group: Patients who elect or are clinically selected to receive an interscalene nerve block/superficial cervical block combined with sedation.
Intraoperative physiological variables, including heart rate, systolic and diastolic blood pressure, oxygen saturation, and respiratory rate, will be continuously monitored throughout the procedure. The study will also record the feasibility of implementing controlled hypotension and analyze its correlation with intraoperative bleeding amounts. To provide a holistic comparison between anesthesia methods, the study will track postoperative recovery metrics, including the total duration of surgery and anesthesia. Additionally, postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 1, 2, 4, 8, 16, and 24 hours post-procedure. The incidence of opioid-related side effects, such as nausea and vomiting, will be monitored and recorded during the postoperative period .
Primary Assessment:
- Surgical View Evaluation: The clarity of the surgical field and the extent to which bleeding obscures visualization are evaluated using a 5-point Likert scale (1 = Poor/No Visualization: Severe bleeding that completely obscures the field; surgery is extremely difficult or impossible without constant suction/lavage; 2 = Fair Visualization: Significant bleeding obscuring the field; frequent suction/lavage is required to proceed; 3 = Moderate Visualization: Moderate bleeding; the anatomy is visible, but occasional suction/lavage is needed to maintain a clear view; 4 = Good Visualization: Mild bleeding; the surgical field is clear with only rare need for suction/lavage; 5 = Excellent/Crystal Clear Visualization: No significant bleeding; the surgical field is perfectly clear throughout the procedure.)
Sample Size: Based on a preliminary analysis conducted at our center, a distinct difference in the primary outcome (Surgical view evaluation) was observed between the two groups (RA: 3.1 ± 1.2 vs. GA: 4.0 ± 1.5). To detect this difference with a Power (1-beta) of 0.80 and an alpha error of 0.05, a sample size of 37 patients per group is required. Accounting for a 10% dropout rate, the study will enroll a total of 82 patients (41 in the GA group and 41 in the RA group).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia Group | – | –Patients undergoing elective shoulder arthroscopy who receive general anesthesia as determined by routine clinical practice and patient preference. |
| Regional Anesthesia Group | – | –Patients undergoing elective shoulder arthroscopy who receive regional anesthesia [interscalene nerve block/superficial cervical block] combined with sedation as determined by routine clinical practice and patient preference. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 to 75 years) who are scheduled to undergo elective shoulder arthroscopy at the Sabuncuoğlu Şerefeddin Training and Research Hospital. These participants are recruited from the patient pool presenting to the Orthopedics and Traumatology clinic for surgical treatment of shoulder pathologies (rotator cuff tears or impingement). Participants include individuals with an ASA physical status of I, II, or III who are capable of providing informed consent .
Key inclusion criteria (4 listed)
- Volunteers aged 18 to 75 years.
- Patients scheduled for elective shoulder arthroscopy.
- Patients with an ASA (American Society of Anesthesiologists) physical status score of I, II, or III.
- Patients capable of providing informed consent.
Key exclusion criteria (5 listed)
- Previous surgical procedure performed on the same shoulder.
- Presence of medical contraindications that could affect the choice of anesthesia (coagulopathy, active infection, severe pulmonary diseases)
- Known allergy to local anesthetics or general anesthesia agents
- History of opioid dependence or chronic pain syndrome
- Presence of neurological disorders, particularly those involving the brachial plexus
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
Surgical View Clarity Score
Time frame: Intraoperative (assessed immediately upon completion of wound closure)
The clarity of the surgical field and the extent to which bleeding obscures visualization are evaluated by the surgeon using a 5-point Likert scale. The scale ranges from 1 (Poor/No Visualization) to 5 (Excellent/Crystal Clear Visualization).
8 secondary outcomes
Surgeon Satisfaction Score
Time frame: Intraoperative (assessed immediately upon completion of wound closure)
Intraarticular Bleeding Severity
Time frame: Intraoperative
Feasibility of Controlled Hypotension
Time frame: Intraoperative
Duration of Surgery
Time frame: Intraoperative
Duration of Anesthesia
Time frame: Intraoperative
Postoperative Pain Score (NRS)
Time frame: Postoperative hours 1, 2, 4, 8, 16, and 24
Incidence of Opioid-Related Side Effects
Time frame: Postoperative 24 hours
Patient Satisfaction Score
Time frame: Postoperative 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- 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.
Ahmet Salih Tüzen, M.D. principal investigator
Izmir Katip Celebi University Atatürk Training and Research Hospital
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 Shoulder Arthroscopy and Interscalene Nerve Block, run by Amasya University 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 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: opening soon, as of the sponsor's last update on 15 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harun Tolga Duran, M.D. (+90 985 65 99, htd0561@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical View Clarity Score (time frame: Intraoperative (assessed immediately upon completion of wound closure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.