NCT06928064

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 20, 2025

Last Update Submit

April 7, 2025

Conditions

Keywords

breast surgerypain sensivity

Outcome Measures

Primary Outcomes (1)

  • Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Lumpectomy

    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

Study Arms (1)

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

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

Interventions

: 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

Having planned BCS with general anesthesia • Being a female patient between the ages of 18-70

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Lutfi Kirdar City Hospital

Istanbul, 34870, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Preoperative PeriodMastectomy, Segmental

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative PeriodSurgical Procedures, OperativePatient CareHealth ServicesHealth Care Facilities Workforce and ServicesMastectomy

Study Officials

  • BANU CEVIK, PROFFESSOR

    DR LUTFI KIRDAR CITY HOSPİTAL

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

March 20, 2025

First Posted

April 15, 2025

Study Start

March 1, 2024

Primary Completion

August 31, 2024

Study Completion

October 23, 2024

Last Updated

April 15, 2025

Record last verified: 2025-04

Locations