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Effect of Patient-Anesthesiologist Gender Concordance and Analgesia Method on Postoperative Pain in Mastectomy Patients

D

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Status

Enrolling

Conditions

Postoperative Pain
Breast Cancer
Mastectomy
Analgesic Use

Study type

Observational

Funder types

Other

Identifiers

NCT07035275
2025-06/86

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Male Anesthesiologist Group
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

Mustafa Kemal SAHIN, M.D; EDA CAFEROGLU, M.D

Data sourced from clinicaltrials.gov

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