Effect of Anesthesia Technique on Surgical View in Shoulder Arthroscopy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAmasya University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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 .
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
82 Participants
are grouped into 2 trial groupsGroup A: General Anesthesia Group
Group B: Regional Anesthesia Group
Trial outcomes
Primary outcomes
1
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).
Time frame
Intraoperative (assessed immediately upon completion of wound closure)Secondary outcomes
1
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.
Time frame
Intraoperative (assessed immediately upon completion of wound closure)2
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.
Time frame
Intraoperative3
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).
Time frame
Intraoperative4
Duration of Surgery
The time in minutes measured from the start of the incision to the completion of wound closure.
Time frame
IntraoperativeSponsors and contacts
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Source ClinicalTrials.gov
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