Effects of Interscalene Block on Visual Clarity in Arthroscopic Surgery (NCT06786013) | Clinical Trial Compass
CompletedNot Applicable
Effects of Interscalene Block on Visual Clarity in Arthroscopic Surgery
Turkey (Türkiye)80 participantsStarted 2025-01-17
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual clarity during arthroscopic rotator cuff repair