Finding studies
Finding studies
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Lead
Koç University
Primary Outcome Measures The primary outcome is the prevalence of chronic pain at 3 months in patients undergoing mastectomy surgery. For patients reporting pain, additional parameters will be assessed, including: Pain characteristics: location, frequency, intensity, and radiation. Factors that exacerbate or alleviate pain. Impact of pain on quality of life (measured on a 1-5 scale). Types and quantities of analgesics used. Secondary Outcome Measures Acute Pain Scores: Pain levels at 1, 6, 12, and 24 hours postoperatively at rest, measured using the Numeric Rating Scale (NRS). Opioid Consumption and Side Effects: Total opioid consumption (morphine and tramadol) within the first 24 hours postoperatively. Incidence of opioid-related side effects, such as nausea, vomiting, and pruritus. Patient Satisfaction and Sleep Quality: Satisfaction with the analgesic method (e.g., very satisfied, satisfied, neutral, dissatisfied, very dissatisfied). Sleep quality ratings (very good, good, moderate, poor, very poor). Willingness to use the same analgesic method again (yes/no). Chronic Pain Impact on Daily Life (for patients with pain at 3 months): Degree of limitation in physical activities, household/work tasks, and social life (scored on a scale from 0 = no limitation to 5 = constant limitation). Impact on psychological well-being (scored on a scale from 0 = no impact to 5 = constant impact). Study Design and Participants This prospective, randomized, controlled study will be conducted at Koç University Hospital. Participants will include 90 patients undergoing elective mastectomy surgery, aged 18-80 years, and classified as ASA I-III according to the American Society of Anesthesiologists. Written informed consent will be obtained from all participants. The sample size calculation was based on a 2020 meta-analysis reporting a 59% prevalence of chronic pain at 3 months in patients without any regional block. Using select-statistics.co.uk software, with a two-proportion sample test, a 50% reduction in chronic pain prevalence was considered significant. With a p-value of 0.05 and 80% power, 43 patients per group were required. To increase robustness and account for potential dropouts, 45 patients per group (90 total) will be enrolled. Randomization and Blinding: Participants will be randomized into two groups using randomizer.org software. RIB will be performed before induction of general anesthesia. No blinding will be performed due to the nature of the intervention.
Age
18–80
Sex
FEMALE
Healthy volunteers
Not accepted
