Amasya University Sabuncuoglu Serefeddin Educational and Research Hospital
Amasya, Turkey (Türkiye)
NCT Number: NCT07343414
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Amasya, Turkey (Türkiye)
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:
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:
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Intraoperative (assessed immediately upon completion of wound closure)
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
The operating surgeon's subjective assessment of the amount of bleeding within the joint during the arthroscopy. This is evaluated using a categorical scale:
Time frame: Intraoperative
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: Intraoperative
The time in minutes measured from the start of the incision to the completion of wound closure.
Time frame: Intraoperative
The total time in minutes from the induction of anesthesia to the cessation of anesthetic effects/emergence.
Time frame: Postoperative hours 1, 2, 4, 8, 16, and 24
Assessment of patient pain intensity using the Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "worst pain imaginable."
Time frame: Postoperative 24 hours
The occurrence of specific side effects associated with opioid use, including nausea, vomiting, and pruritus (itching).
Time frame: Postoperative 24 hours
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)
Contact information is provided by the study sponsor or research team.
Bülent Meriç Çam, M.D.
CONTACT
Harun Tolga Duran, M.D.
CONTACT
Amasya University
Other
Impact of Anesthesia Method on Surgical View and Surgeon Satisfaction During Shoulder Arthroscopy: A Prospective Observational Study
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