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Clinical Trials in Singapore / NCT03408717
Active, not recruiting Observational

Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery

NCT03408717 · tracked via the Priya Life Science Singapore tracker
Phase
Observational
Started
2018-01-03
Last updated
2026-08-07

Condition(s) studied

Breast CancerChronic PainAcute PainDepression, Anxiety

Investigational drug(s) / intervention(s)

QuestionnairesMechanical Temporal Summation assessmentPain threshold assessment

Questionnaires: Questionnaires including Pain catastrophizing scale (PCS), Central Sensitisation Inventory (CSI), Coping Strategies Questionnaire-Revised (CSQ-R), Brief Symptom Inventory-18 (BSI-18), Perceived Stress Scale (PSS), EQ-5D-3L and Eysenck Personality Questionnaire (EPQ) will be administered to the patient.

Mechanical Temporal Summation assessment: A 180 gram von Frey filament is applied on the subject's forearm. Patient will then be asked to rate the pinprick pain score on a verbal rating scale, 0-100. Following this, 10 consecutive touches at random locations are applied with a 1 second interstimulus interval and within a 1 cm diameter circle. The patient will then be asked to rate the 10th pain score (0-100). The Mechanical Temporal Summation Score is obtained by the difference between the 11th pain score and the 1st pain score. If the score is greater than zero, the patient is implied to have presence of Mechanical Temporal Summation.

Pain threshold assessment: Pressure is applied 90 degree straight down force on the subject's right/left centre of the trapezius muscle using an algometer, with a speed of pressure \~ 1kgf/s. The above procedure is then repeated 3 times at each site (left/right) which is indicated on the pressure mark with each time having the reading recorded. When patient shows no response ≥ 6kgf, the threshold is recorded as 6kgf. The patient upon feeling pain will say stop or raise the hand to terminate the test. The mean value is obtained by averaging the readings and will then be recorded as the threshold estimate.

Study summary

Pre-existing pain and severe postoperative pain are predictors of persistent pain after surgery, but a complete understanding on the development of persistent pain is still lacking. The study aims to identify clinically relevant and genetic risk factors for persistent postsurgical pain that can be reliably distinguished statistically.

Eligibility

Sex
FEMALE
Min age
21 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Aged between 21 - 80 year old; * Healthy and/or have systemic medical conditions as reviewed by anaesthetist for surgery (ASA 1-3); * Undergoing breast cancer surgery. Exclusion Criteria: * History of intravenous drug or opioid abuse; * Current chronic daily treatment with corticosteroids (excluding inhaled steroids); * Previous history of chronic pain syndrome; * Obstetric patients.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Duke University Medical Center Durham North Carolina
KK Women's and Children's Hospital Singapore Singapore

More KK Women's and Children's Hospital trials in Singapore

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03408717 on ClinicalTrials.gov ↗ ← All trials in Singapore