Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery

NCT03408717 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2024-10-09

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • Duke University

    collaborator OTHER
  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Ban Leong Sng, FANZCA · KK Women's and Children's Hospital

  • Ashraf Habib, MBBCh, FRCA · Duke University

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • United States
  • Singapore

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03408717 on ClinicalTrials.gov