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

NCT07035275 | Completed

• 1 other identifier: 2025-06/86
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Postoperative Pain; Analgesic Use; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score

  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)

  1, 6, 12, and 24 hours after surgery

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study will enroll only female participants, as it is limited to patients undergoing mastectomy for breast cancer, a procedure performed exclusively in women within the study setting.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of female patients aged 18 years and older who are diagnosed with breast cancer and scheduled to undergo elective mastectomy at Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital. All participants must have an ASA physical status classification of I-III, complete preoperative and postoperative data, and provide voluntary written informed consent. Patients undergoing emergency surgery, those with incomplete or erroneous data, or those undergoing concurrent major surgery will be excluded.

You may qualify if:

• 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

You may not qualify if:

• Patients undergoing emergency surgery
• Incomplete or erroneous data records
• Patients undergoing concurrent major surgery

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

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

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Related Publications (3)

• Ikesu R, Gotanda H, Russell TA, Maggard-Gibbons M, Russell MM, Yoshida R, Li R, Klomhaus A, de Virgilio C, Tsugawa Y. Long-Term Postoperative Outcomes by Surgeon Gender and Patient-Surgeon Gender Concordance in the US. JAMA Surg. 2025 Jun 1;160(6):624-632. doi: 10.1001/jamasurg.2025.0866.

  PMID: 40266610 BACKGROUND

• Roter DL, Hall JA, Aoki Y. Physician gender effects in medical communication: a meta-analytic review. JAMA. 2002 Aug 14;288(6):756-64. doi: 10.1001/jama.288.6.756.

  PMID: 12169083 BACKGROUND

• Street RL Jr, O'Malley KJ, Cooper LA, Haidet P. Understanding concordance in patient-physician relationships: personal and ethnic dimensions of shared identity. Ann Fam Med. 2008 May-Jun;6(3):198-205. doi: 10.1370/afm.821.

  PMID: 18474881 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Mustafa Kemal SAHIN, M.D

  MUSTAFA KEMAL ŞAHİN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: June 16, 2025
• Primary Completion: August 16, 2025
• Study Completion: September 16, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)