Clinical trial · Observational
Postoperative Pain, Central Sensitization, and Sleep Quality in Breast Cancer Surgery Patients
Investigation of the Relationship Between Postoperative Pain and Both Central Sensitization Severity and Sleep Quality in Patients Undergoing Breast Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Surgery | — | UNRESOLVED | — |
| Central Sensitization | — | UNRESOLVED | — |
| Postoperative Pain | — | UNRESOLVED | — |
| Sleep Quality | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Good Sleep Quality Group
- description
- 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.
- label
- Poor Sleep Quality Group
- description
- 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.
- label
- Low Central Sensitization Severity Group
- description
- 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.
- label
- High Central Sensitization Severity Group
- description
- 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
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available