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NCT Number: NCT07035275

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

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.

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Key information

Conditions

Breast Cancer Analgesic Use Breast Diseases Breast Neoplasms Mastectomy Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative Pain Score

    Time frame: 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 outcomes

  1. Total Analgesic Consumption

    Time frame: 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.

  2. Additional Analgesic Requirement

    Time frame: 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.

  3. Patient Satisfaction with Anesthesia and Pain Management

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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