Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery

NCT03408717 | Active Not Recruiting

• 1 other identifier: 2017/2805
• Study Type: observational
• Target: 220
• Locations: 2 countries
• Sites: 2

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.

Conditions

Breast Cancer; Chronic Pain; Acute Pain; Depression, Anxiety

Keywords

Breast cancer; Chronic pain; Acute Pain; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Persistent pain at 4 months after surgery

  Persistent pain is defined as having one of the below criteria at 4 months after surgery: i) having pain score at rest (Numeric Rating Scale 0 to 100) of 30 or more; or ii) having pain score on movement (Numeric Rating Scale 0 to 100) of 30 or more; or iii) or "yes" to one of the seven questions on the presence of pain in daily life activities (mood, walking, carrying heavy loads, work, relations with people, sleep, enjoyment of life)

  4 months after surgery

Secondary Outcomes (3)

• Persistent pain at 6 months after surgery

  6 months after surgery

• Maximum Acute post-operative pain score

  Up to 3 days after surgery

• Opioid consumption

  Up to 3 days after surgery

Study Arms (1)

Persistent post surgical pain (PPSP)

Questionnaires, Mechanical Temporal Summation assessment and pain threshold assessment will be assigned to patient. Within this cohort, some patients will have high pain score recorded (persistent pain) during the follow-up evaluations at 4 and 6 months.

Other: Questionnaires; Other: Mechanical Temporal Summation assessment; Other: Pain threshold assessment

Interventions

Questionnaires OTHER

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.

Persistent post surgical pain (PPSP)

Mechanical Temporal Summation assessment OTHER

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.

Also known as: MTS

Persistent post surgical pain (PPSP)

Pain threshold assessment OTHER

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.

Also known as: Pressure pain

Persistent post surgical pain (PPSP)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: Only females who undergo breast surgery will be included in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing breast cancer surgery

You may qualify if:

• 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.

You may not qualify if:

• History of intravenous drug or opioid abuse;
• Current chronic daily treatment with corticosteroids (excluding inhaled steroids);
• Previous history of chronic pain syndrome;
• Obstetric patients.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Duke University: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be extracted from venous blood using the Puregene method at the Research Laboratory of the mentioned site. Known functional polymorphisms in Catechol-O-methyltransferase (COMT), Calcium channel, voltage-dependent, gamma subunit (CACNG2) and Sodium Voltage-Gated Channel Alpha Subunit 9 (SCN9A) gene with evidence of associations with depression, pain, stress and anxiety would be determined by the Taqman allelic discrimination assay method. Alleles will be called using the software. Genetic data will be analyzed for association with the presence of persistent pain.

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain; Acute Pain; Depression; Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ban Leong Sng, FANZCA

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

• Ashraf Habib, MBBCh, FRCA

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 24, 2018
• Study Start: January 3, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); US (1)