Analgesic Use, Breast Cancer, Mastectomy, Postoperative Pain
Conditions
Brief summary
This prospective observational study aims to evaluate the effect of anesthesiologist gender and patient-anesthesiologist gender concordance, as well as the analgesia method, on postoperative pain levels and analgesic requirements in patients undergoing elective mastectomy for breast cancer. The study will also investigate the impact of these factors on intraoperative and postoperative anesthesia-related complications. Findings are expected to contribute to the understanding of gender-based differences in patient outcomes and guide improvements in perioperative care.
Detailed description
This study will be conducted at Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital and will include patients aged 18 years and older who are scheduled for elective mastectomy due to breast cancer. The primary objective is to assess whether the gender of the anesthesiologist and the gender concordance between patient and anesthesiologist influence postoperative pain scores, total analgesic consumption, the need for additional analgesics, and anesthesia-related complications. The study will also examine the role of different analgesia methods (nerve block, PCA, intravenous analgesics) in these relationships. Patient and anesthesiologist assignments will follow the hospital's routine workflow, with no intervention by the research team. All data will be collected prospectively using standardized forms, including demographic information, surgical and anesthesia details, and postoperative outcomes. Pain will be assessed at multiple time points using validated scales (VAS or NRS), and patient satisfaction with anesthesia and pain management will be measured using a Likert scale. A minimum of 120 patients will be enrolled based on power analysis. Inclusion criteria are: age 18 or older, ASA score 1-3, complete pre- and postoperative data, and informed consent. Exclusion criteria include emergency surgery, incomplete or erroneous data, and concurrent major surgery. Statistical analyses will include descriptive statistics, chi-square or Fisher's exact test for categorical variables, t-test or Mann-Whitney U test for continuous variables, and multivariate logistic regression to assess independent effects. The study is entirely observational, with no changes to standard patient care.
Interventions
None listed
Sponsors
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
* Female patients aged 18 years or older * Diagnosed with breast cancer and scheduled for elective mastectomy * ASA physical status classification I-III * Complete availability of preoperative and postoperative data * Voluntary written informed consent to participate in the study
Exclusion criteria
* Patients undergoing emergency surgery * Incomplete or erroneous data records * Patients undergoing concurrent major surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | 1, 6, 12, and 24 hours after surgery | Assessment of postoperative pain intensity using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS) at specified time points after surgery. The VAS is a 10-centimeter line ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS is a numeric scale from 0 (no pain) to 10 (worst possible pain). Pain scores will be recorded at 1, 6, 12, and 24 hours postoperatively. Higher scores indicate greater pain intensity. The primary outcome is the comparison of pain scores between patients managed by male versus female anesthesiologists. Units of Measure: Units on a scale (0 = no pain, 10 = worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Analgesic Consumption | Within 24 hours after surgery | The total amount of analgesic medication administered to the patient within the first 24 hours after surgery, including type, dosage, and frequency. This will be compared between patients managed by male and female anesthesiologists. |
| Additional Analgesic Requirement | Within 24 hours after surgery | The proportion of patients requiring additional (rescue) analgesic medication within the first 24 hours postoperatively. This will be recorded and compared between the two groups. |
| Patient Satisfaction with Anesthesia and Pain Management | 24 hours after surgery | Patient satisfaction will be assessed at 24 hours postoperatively using a 5-point Likert scale. The scale ranges from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction with anesthesia and pain management. Units of Measure: Points on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMustafa Kemal SAHIN, M.D
MUSTAFA KEMAL ŞAHİN
Outcome results
None listed