Postoperative PainNCT07077421
Postoperative Pain, Central Sensitization, and Sleep Quality in Breast Cancer Surgery Patients
An observational study of Postoperative Pain and Breast Cancer Surgery, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Postoperative Pain, Breast Cancer Surgery, Central Sensitization
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Üniversitesi-Cerrahpaşa Cerrahpaşa Tıp Fakültesi
Istanbul, 34147
About this study
Official title: Investigation of the Relationship Between Postoperative Pain and Both Central Sensitization Severity and Sleep Quality in Patients Undergoing Breast Cancer Surgery
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.
Read more
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.
Read the 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.
- Medical subject headings
- Pain, Postoperative, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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
- = Mild nausea only, no vomiting
- = Moderate nausea and/or one episode of vomiting
- = Severe nausea and/or two or more episodes of 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.
Measured: 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.
Measured: Day 0 (30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start13 Mar 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Hilal Durukan Gündoğan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077421
- Sponsor's protocol ID
- 2025/81
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Postoperative Pain and Both Central Sensitization Severity and Sleep Quality in Patients Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT07077421
- Acronym / sponsor ID
- 2025/81
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Sedation Level Assessed by Ramsay Sedation Scale (RSS)
Time frame: 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)
Time frame: Day 0 (30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours post-surgery)
Delirium Assessment Using the Nursing Delirium Screening Scale (NuDESC)
Time frame: Day 0 (30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours post-surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Breast Cancer Surgery, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.