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| Name | Class |
|---|---|
| Duke University | OTHER |
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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.
The study will focus on: (i) risk factors representing biopsychosocial processes that influence chronic pain, such as pain and psychological vulnerability; (ii) genetic factors relating to mechanistic pathways to persistent pain generation. Patients will be recruited from those undergoing breast cancer surgery at the mentioned site. Pain and anxiety assessment will be conducted via visual analogue scoring, mechanical temporal summation assessment and a series of questionnaires. After the surgery, all patients will be given appropriate analgesia, and the pain score and analgesia usage will be recorded. Phone survey will be conducted 4 and 6 months, respectively, after surgery to determine the outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent pain at 6 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) |
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Inclusion Criteria:
Exclusion Criteria:
Only females who undergo breast surgery will be included in this study.
Patients undergoing breast cancer surgery
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| Name | Affiliation | Role |
|---|---|---|
| Ban Leong Sng, FANZCA | KK Women's and Children's Hospital | Principal Investigator |
| Ashraf Habib, MBBCh, FRCA | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| KK Women's and Children's Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2020 |
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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.
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| 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. |
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| 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. |
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| 6 months after surgery |
| Maximum Acute post-operative pain score | The maximum number of patient-reported post-operative pain score (Numeric Rating Scale 0 to 100) at 0 - 72 hours | Up to 3 days after surgery |
| Opioid consumption | The total opioid consumption (morphine/ fentanyl/ hydromorphone/ oxycodone/ hydrocodone etc) throughout the 72 hours. The opioid consumption will be converted using oral morphine equivalent (OME) conversion calculations. | Up to 3 days after surgery |
| Singapore |
| 229899 |
| Singapore |
| Jan 17, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D059350 | Chronic Pain |
| D059787 | Acute Pain |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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