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临床试验/NCT07035275
NCT07035275已完成不适用

The Effect of Patient-Anesthesiologist Gender Concordance and Analgesia Method on Postoperative Pain and Analgesic Requirement in Patients Undergoing Mastectomy Surgery

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年6月16日最近更新:
适应症

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

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

发起方
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Kemal ŞAHİN

M.D

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

研究点 (1)

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