Investigation of the Relationship Between Postoperative Pain and Both Central Sensitization Severity and Sleep Quality in Patients Undergoing Breast Cancer Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Postoperative Acute Pain Intensity Measured by the Numeric Rating Scale (NRS)
Study Overview
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.
Detailed Description
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Postoperative Acute Pain Intensity Measured by the Numeric Rating Scale (NRS)
Time Frame: Day 0 (30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours post-surgery)
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.
Secondary Outcomes
- 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))
Investigators
Nur Hilal Durukan Gündoğan
Medical Doctor
Istanbul University - Cerrahpasa