Acute Pain / Pain threshold assessment / Questionnaires · Observational Study

Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned observational study registered to identify clinical and genetic risk factors for persistent postsurgical pain after breast surgery. No results have been posted to the registry; the study remains active but not recruiting. The work aims to clarify the mechanisms underlying persistent postsurgical pain, a recognised problem for which prediction tools remain incomplete.

What was studied

Observational. Breast Cancer, Chronic Pain, Acute Pain, Depression, Anxiety; Female; age from 21 Years; to 80 Years. Intervention: Persistent post surgical pain (PPSP). n = 220. 2 sites: United States, Singapore.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active observational registry study with no reported results; it aims to identify risk factors for persistent postsurgical pain but carries no outcome data yet.

Study design

As stated by the source record.

MethodsOther model. Prospective time perspective. Primary outcome measure: Persistent pain at 4 months after surgery (assessed at 4 months after surgery)

DesignObservational

PopulationBreast Cancer, Chronic Pain, Acute Pain, Depression, Anxiety; Female; age from 21 Years; to 80 Years

Sample size220

InterventionPersistent post surgical pain (PPSP)

Setting2 sites: United States, Singapore

Reported figures

Quoted from the source exactly as published.

Planned enrollment220

Primary outcome measurePersistent pain at 4 months after surgery

Follow-up timepoint4 months after surgery

Caveats

This is a registry record only; no results are posted or reported.
Study design details (inclusion/exclusion criteria, specific interventions, analysis plan) not provided in registry text.
Genetic and clinical risk factors to be identified are not yet determined.
No outcome data, effect sizes, or statistical comparisons available for clinical decision-making.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational design with prospective assessment of pain and risk factors.

Directness

strong

Directly measures persistent pain at 4 months post-surgery in breast surgery patients.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

No methodology detail provided; risk of bias assessment premature without results.

Sample adequacy

moderate

Estimated 220 participants planned; adequate for observational risk factor analysis.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT03408717). This is a study registration, not published results. Lead sponsor: KK Women's and Children's Hospital. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 220 participants (ESTIMATED). Conditions: Breast Cancer, Chronic Pain, Acute Pain, Depression, Anxiety. Interventions: OTHER: Questionnaires; OTHER: Mechanical Temporal Summation assessment; OTHER: Pain threshold assessment. Primary outcome measures: Persistent pain at 4 months after surgery , 4 months after surgery. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Acute PainNCT03408717Pain threshold assessmentKK Women's and Children's HospitalQuestionnairesBreast CancerChronic PainMechanical Temporal Summation assessment