Clinical trial NCT03408717: Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery
Official title: Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery: A Prospective Cohort Study (Breast CAncer Surgery Postsurgical Pain)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Chronic Pain
Acute Pain
Depression, Anxiety
Keywords: Breast cancer
Chronic pain
Acute Pain
Depression
Anxiety
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Duke University
First posted: 2018-01-24
Enrollment: 220
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing breast cancer 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Persistent pain at 4 months after surgery
timeFrame: 4 months after surgery
Secondary outcomes:
measure: Persistent pain at 6 months after surgery
timeFrame: 6 months after surgery
measure: Maximum Acute post-operative pain score
timeFrame: Up to 3 days after surgery
measure: Opioid consumption
timeFrame: Up to 3 days after surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban Leong Sng, FANZCA
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Ashraf Habib, MBBCh, FRCA
role: PRINCIPAL_INVESTIGATOR
References: