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

NCT ID: NCT07035275

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-16

Study Completion Date

2025-09-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Mastectomy Postoperative Pain Analgesic Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mustafa Kemal ŞAHİN

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mustafa Kemal SAHIN, M.D

Role: PRINCIPAL_INVESTIGATOR

MUSTAFA KEMAL ŞAHİN

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mustafa Kemal SAHIN, M.D

Role: CONTACT

+905075800976

EDA CAFEROGLU, M.D

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mustafa Kemal SAHIN, Dr

Role: primary

+905075800976

Eda Caferoglu, Dr

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 40266610 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12169083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18474881 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-06/86

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chronic Post Surgical Pain-Cardiac
NCT06382077 ACTIVE_NOT_RECRUITING