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

NCT ID: NCT07077421

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-13
• Study Completion Date: 2025-06-30

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).

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Nur Hilal Durukan Gündoğan

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İstanbul Üniversitesi-Cerrahpaşa Cerrahpaşa Tıp Fakültesi

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2025/81

Identifier Type: -

Identifier Source: org_study_id