Pain Sensitivity Questionnaire Applied in Preoperative Period in Lumpectomy (Lumpectomy)

April 7, 2025 updated by: SEVDE RUMEYSA YILMAZ, Dr. Lutfi Kirdar Kartal Training and Research Hospital

Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Breast-Conserving Surgery (Lumpectomy)

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.

Study Overview

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

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34870
        • Dr Lutfi Kirdar City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients between the ages of 18-70 who are scheduled for breast-conserving surgery

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: BANU CEVIK, PROFFESSOR, Dr Lutfi Kirdar City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

October 23, 2024

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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