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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.
This prospective observational cohort study is designed to evaluate the association between preoperative central sensitization levels, sleep quality, and acute postoperative pain intensity in female patients undergoing breast cancer surgery. The study is being conducted at Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty, Department of Anesthesiology and Reanimation, in collaboration with the Department of General Surgery, from March 2025 to June 2025, following ethics committee approval and prospective registration.
A total of 41 female patients, aged between 18 and 80 years, undergoing unilateral breast surgery with sentinel lymph node biopsy (SLNB)-including simple mastectomy, breast-conserving surgery, or mastectomy with immediate reconstruction-are included. All participants provide written informed consent before enrollment.
Preoperative assessments are performed one day prior to surgery. Central sensitization is measured using the Central Sensitization Inventory (CSI), a 25-item self-report questionnaire assessing symptoms commonly associated with central sensitization. A CSI-A score ≥40 is considered indicative of high central sensitization. Sleep quality is evaluated with the Pittsburgh Sleep Quality Index (PSQI), a validated instrument assessing sleep characteristics over the past month; PSQI scores ≥5 are accepted as reflecting poor sleep quality.
All patients receive standardized general anesthesia and multimodal analgesia including:
Induction: Fentanyl 2 mcg/kg (lean body weight), propofol 2 mg/kg (lean body weight), rocuronium 0.6 mg/kg (actual body weight).
Maintenance: Sevoflurane and additional opioid supplementation as needed. Intraoperative analgesia: Morphine 0.05 mg/kg (lean body weight). Postoperative analgesia: Scheduled paracetamol and NSAIDs; opioids as rescue medication if required.
Pain severity is measured using the Numeric Rating Scale (NRS) at five postoperative time points: 30 minutes, 2, 6, 12, and 24 hours. Additional assessments include:
Sedation level: Ramsay Sedation Scale (RSS) Nausea and vomiting: Verbal Descriptive Scale (VDS) Delirium screening: Nursing Delirium Screening Scale (NuDESC) Participants are categorized into groups according to their CSI and PSQI scores. Postoperative pain scores and secondary outcomes are compared across these groups using non-parametric statistical methods (e.g., Mann-Whitney U test for independent samples). Correlation analyses (Spearman's rank) are performed to assess relationships between CSI, PSQI, and postoperative pain scores.
The primary objective is to determine whether high central sensitization and/or poor sleep quality are predictive of increased acute postoperative pain. Secondary objectives include evaluating the relationship between preoperative risk factors and sedation, nausea/vomiting, and delirium outcomes.
A power analysis was conducted based on expected effect sizes from previous literature, targeting a minimum of 31 participants for 80% statistical power with an alpha of 0.05. A 20% dropout margin was included, resulting in a final sample size of 41 participants.
All data are collected using standardized case report forms. Data entry is conducted by trained personnel and monitored for consistency and completeness. Ethical approval was obtained from the institutional review board prior to participant recruitment. The study does not receive external funding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation Level Assessed by Ramsay Sedation Scale (RSS) | Sedation level will be assessed using the Ramsay Sedation Scale (RSS; range 1-6, where higher scores indicate deeper levels of sedation). Assessments will be conducted 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 |
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InclusionCriteria:
ExclusionCriteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İstanbul Üniversitesi-Cerrahpaşa Cerrahpaşa Tıp Fakültesi | Istanbul | 34147 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Postoperative Nausea and Vomiting Severity Scored on a 4-Point Scale (0-3) | Postoperative nausea and vomiting (PONV) will be assessed using a 4-point verbal rating scale. Patients will be asked to rate their overall PONV severity as follows: 0 = No nausea or vomiting
Higher scores indicate more severe PONV. Evaluations will be performed 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) |
| Delirium Assessment Using the Nursing Delirium Screening Scale (NuDESC) | Delirium will be assessed using the Nursing Delirium Screening Scale (NuDESC), a validated 5-item observational tool. Each item is scored from 0 to 2, yielding a total score range of 0-10. A total score ≥2 is considered indicative of delirium. Assessments will be conducted 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) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |