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ACTIVE NOT RECRUITING
NCT03408717

Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery

Sponsor: KK Women's and Children's Hospital

View on ClinicalTrials.gov

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.

Official title: Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery: A Prospective Cohort Study (Breast CAncer Surgery Postsurgical Pain)

Key Details

Gender

FEMALE

Age Range

21 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

220

Start Date

2018-01-03

Completion Date

2026-12-31

Last Updated

2024-10-09

Healthy Volunteers

No

Interventions

OTHER

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.

OTHER

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.

OTHER

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.

Locations (2)

Duke University Medical Center

Durham, North Carolina, United States

KK Women's and Children's Hospital

Singapore, Singapore