The Effect of Patient-Anesthesiologist Gender Concordance and Analgesia Method on Postoperative Pain and Analgesic Requirement in Patients Undergoing Mastectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients undergoing emergency surgery
- •Incomplete or erroneous data records
- •Patients undergoing concurrent major surgery
研究组 & 干预措施
Male Anesthesiologist Group
Patients undergoing elective mastectomy for breast cancer who receive anesthesia care from a male anesthesiologist. All anesthesia and analgesia procedures will be performed according to the hospital's standard protocols. The type of analgesia (nerve block, patient-controlled analgesia [PCA], or intravenous analgesics) will be recorded, but not influenced by the research team. Postoperative pain scores, analgesic requirements, and anesthesia-related complications will be prospectively monitored and documented.
Female Anesthesiologist Group
Patients undergoing elective mastectomy for breast cancer who receive anesthesia care from a female anesthesiologist. All anesthesia and analgesia procedures will be performed according to the hospital's standard protocols. The type of analgesia (nerve block, patient-controlled analgesia [PCA], or intravenous analgesics) will be recorded, but not influenced by the research team. Postoperative pain scores, analgesic requirements, and anesthesia-related complications will be prospectively monitored and documented.
结局指标
主要结局
Postoperative Pain Score
时间窗: 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)
次要结局
- Total Analgesic Consumption(Within 24 hours after surgery)
- Additional Analgesic Requirement(Within 24 hours after surgery)
- Patient Satisfaction with Anesthesia and Pain Management(24 hours after surgery)
研究者
Mustafa Kemal ŞAHİN
M.D
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
