- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06928064
Pain Sensitivity Questionnaire Applied in Preoperative Period in Lumpectomy (Lumpectomy)
Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Breast-Conserving Surgery (Lumpectomy)
Study Overview
Status
Conditions
Detailed Description
Objective: The Pain Sensitivity Questionnaire (PSQ) is a clinically valuable tool that has been shown to correlate with various experimental pain sensitivity assessments in healthy individuals and patients with chronic pain. In this study, we aimed to investigate the effectiveness of the PSQ in predicting postoperative pain in patients undergoing breast-conserving surgery.
Materials and Methods: This study included 74 patients over the age of 18 with American Society of Anesthesiologists (ASA) scores of I, II, or III, who were scheduled to undergo breast-conserving surgery. Ethical approval from the local ethics committee and written informed consent from each patient were obtained. Patient data, including age, ASA score, and comorbidities, were collected, and contact details were recorded for postoperative follow-up.
The PSQ was administered to all patients during the preoperative period to assess their pain sensitivity. Anesthesia induction and maintenance followed a standardized protocol on the day of surgery. The intraoperative analgesic consumption and the duration of the surgery were documented. Postoperative assessments were conducted 24 hours after the surgery in the general surgery ward, where analgesic use and short pain inventory scores were recorded. Patients were followed up one month postoperatively, and their pain levels were assessed using the Numeric Rating Scale (NRS).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34870
- Dr Lutfi Kirdar City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Having planned BCS with general anesthesia
- Being a female patient between the ages of 18-70
- Being evaluated as American Society of Anesthesiologists (ASA) I, II, III
- Having given written consent to participate in the study
Exclusion Criteria:
Pregnancy
- Being assessed as ASA IV
- Having advanced cardiac, pulmonary and cerebrovascular disease, advanced renal failure, liver failure, history of fentanyl/remifentanyl hypersensitivity, Alzheimer's disease, mental retardation
- Being at a mental level that cannot comply with the evaluations within the scope of the study
- Not having given written consent for any reason
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Having planned BCS with general anesthesia • Being a female patient between the ages of 18-70
Having planned BCS with general anesthesia Being a female patient between the ages of 18-70 Being evaluated as American Society of Anesthesiologists (ASA) I, II, III Having given written consent to participate in the study
|
: This study included 74 patients over the age of 18 with American Society of Anesthesiologists (ASA) scores of I, II, or III, who were scheduled to undergo breast-conserving surgery. Ethical approval from the local ethics committee and written informed consent from each patient were obtained. Patient data, including age, ASA score, and comorbidities, were collected, and contact details were recorded for postoperative follow-up. The PSQ was administered to all patients during the preoperative period to assess their pain sensitivity. Anesthesia induction and maintenance followed a standardized protocol on the day of surgery. The intraoperative analgesic consumption and the duration of the surgery were documented. Postoperative assessments were conducted 24 hours after the surgery in the general surgery ward, where analgesic use and short pain inventory scores were recorded. Patients were followed up one month postoperatively, and their pain levels were assessed using the Numeric Rating |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Lumpectomy
Time Frame: From March 2024 to August 2024
|
This study included 74 patients over the age of 18 with American Society of Anesthesiologists (ASA) scores of I, II, or III, who were scheduled to undergo breast-conserving surgery.
Ethical approval from the local ethics committee and written informed consent from each patient were obtained.
Patient data, including age, ASA score, and comorbidities, were collected, and contact details were recorded for postoperative follow-up.The aim was to examine the relationship between the PSQ score measured in the preoperative period and the degree of pain in the postoperative period.
BPI score and NRS score were used in the evaluation of postoperative pain.
|
From March 2024 to August 2024
|
Collaborators and Investigators
Investigators
- Study Chair: BANU CEVIK, PROFFESSOR, Dr Lutfi Kirdar City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRYILMAZ
- 010.99/16 (Other Identifier: Dr Lutfi Kirdar City Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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