Postoperative Pain, Central Sensitization, and Sleep Quality in Breast Cancer Surgery Patients

NCT07077421 | Completed

• 1 other identifier: 2025/81
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to investigate whether preoperative central sensitization and sleep quality are associated with acute postoperative pain levels in patients undergoing breast cancer surgery. The study includes 41 female patients scheduled for unilateral breast cancer surgery. Before surgery, participants are evaluated using two self-report questionnaires: the Central Sensitization Inventory (CSI) and the Pittsburgh Sleep Quality Index (PSQI). Based on their scores, participants are categorized into groups according to central sensitization level and sleep quality. After surgery, all participants receive a standardized multimodal analgesia protocol. Pain severity is measured using the Numeric Rating Scale (NRS) at five time points within the first 24 hours: 30 minutes, 2, 6, 12, and 24 hours postoperatively. Additional assessments include sedation level (Ramsay Sedation Scale), nausea and vomiting (Verbal Descriptive Scale), and presence of delirium (Nursing Delirium Screening Scale - NuDESC). The primary question this study seeks to answer is whether higher levels of central sensitization and/or poor sleep quality prior to surgery are predictive of greater acute postoperative pain.

Conditions

Postoperative Pain; Breast Cancer Surgery; Central Sensitization; Sleep Quality

Outcome Measures

Primary Outcomes (1)

• Postoperative Acute Pain Intensity Measured by the Numeric Rating Scale (NRS)

  Postoperative acute pain intensity will be assessed using the Numeric Rating Scale (NRS; range 0-10, where 0 = no pain and 10 = worst imaginable pain) at rest and during movement. Measurements will be taken at 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.

  Day 0 (30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours post-surgery)

Secondary Outcomes (3)

• Sedation Level Assessed by Ramsay Sedation Scale (RSS)

  Day 0 (30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours post-surgery

• Postoperative Nausea and Vomiting Severity Scored on a 4-Point Scale (0-3)

  Day 0 (30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours post-surgery)

• Delirium Assessment Using the Nursing Delirium Screening Scale (NuDESC)

  Day 0 (30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours post-surgery)

Study Arms (4)

Good Sleep Quality Group

Participants with Pittsburgh Sleep Quality Index (PSQI) score less than 5, indicating good sleep quality. No intervention is applied to alter sleep patterns; this is a stratification based on preoperative sleep assessment.

Poor Sleep Quality Group

Participants with PSQI score of 5 or greater, indicating poor sleep quality. This group is used to assess the relationship between preoperative sleep disturbance and postoperative pain outcomes. No intervention is applied.

Low Central Sensitization Severity Group

Participants with Central Sensitization Inventory (CSI) score below 40, indicating low central sensitization severity. Used for comparative analysis of postoperative pain scores. No therapeutic intervention applied.

High Central Sensitization Severity Group

Participants with CSI score of 40 or greater, indicating high central sensitization severity This grouping aims to evaluate the effect of central sensitization on postoperative pain perception and analgesic needs. No intervention administered.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of female patients aged 18 to 80 years who were admitted for elective breast cancer surgery at the Department of Anesthesiology and Reanimation, Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty Hospital. Participants were selected consecutively among those scheduled for unilateral simple mastectomy, breast-conserving surgery, or mastectomy combined with immediate breast reconstruction. All surgeries were performed under general anesthesia. Preoperative evaluations and postoperative follow-up (within 24 hours) were conducted in a tertiary-care academic hospital setting. Patients were evaluated using standardized self-report questionnaires.

InclusionCriteria: * Female patients aged between 18 and 80 years * Scheduled to undergo one of the following unilateral breast cancer surgeries with sentinel lymph node biopsy (SLNB): * Simple mastectomy * Breast-conserving surgery (BCS) * Simple mastectomy with immediate breast reconstruction * ASA Physical Status Classification I-III * Able to understand the study procedure and provide informed consent * Fluent in Turkish and capable of completing self-report questionnaires * Preoperative completion of the following assessments: * Central Sensitization Inventory (CSI) * Pittsburgh Sleep Quality Index (PSQI) ExclusionCriteria: * Pregnant or lactating women * Allergy or contraindication to any component of the analgesic regimen (e.g., paracetamol, dexketoprofen, tramadol, fentanyl, or morphine) * Planned or performed intraoperative regional nerve block (e.g., paravertebral or PECS block) * Use of sedative-hypnotic drugs, opioids, or gabapentinoids within the last 7 days * History of prior breast or axillary surgery * Conversion to emergency surgery or development of major intraoperative complications * Admission to the intensive care unit (ICU) postoperatively * Patient refusal to participate in postoperative assessments * Evidence of metastatic disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul Üniversitesi-Cerrahpaşa Cerrahpaşa Tıp Fakültesi

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 22, 2025
• Study Start: March 13, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

TU (1)