Chronic Postsurgical Pain: Multivariate Prediction Model
- Conditions
- Post Surgical PainPostoperative Pain, ChronicPost Operative Pain
- Interventions
- Procedure: Chronic Post Surgery Pain (CPSP)
- Registration Number
- NCT06417528
- Lead Sponsor
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Brief Summary
The goal of this observational study is to identify the risk factors of Chronic Postoperative pain (or Chronic Post Surgery Pain - CPSP) three months after surgery and, subsequently. the development of a risk index to identify high-risk patients considering the multifactorial etiology of CPOP in adult patients undergoing any type of elective surgery.
- Detailed Description
The study aims to identify the risk factors of CPSP three months after surgery and subsequently develop a risk index to identify high-risk patients considering the multifactorial etiology of CPSP.
A comprehensive entry pool was derived from a systematic literature search. Data collection will record parameters at four different time points: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; postoperative period (from the third month after the operation).
The outcome variable is the presence of CPSP assessed 3 months postoperatively and defined as a mean pain intensity of at least 3 on the NRS (one-dimensional pain scale from 0 to 10) over the past three days and pain localized to the field surgical (or to the area of the lesion) projected into the innervation territory of a nerve located in this area, or referred to a dermatome.
Four separate forecasting models will be developed using data derived from surveys carried out at relevant time points for the development of the risk index.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Adult Patients
- Patients undergoing any type of elective surgery
- Patients with sensory impairments
- Patients unable to communicate
- Patients with cognitive impairments
- Patients with insufficent knowledge of the language
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Surgery Patients Chronic Post Surgery Pain (CPSP) Data collection will record parameters of patients undergoing surgery at four different times: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; and postoperative period (from the third month following surgery).
- Primary Outcome Measures
Name Time Method Chronic Post Surgery Pain (CPSP) 3 months Presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 points on the NRS scale (one-dimensional pain scale - from 0 to 10 points) in the last three days and pain localized to the surgical field (or in the lesion area) projected into the innervation territory of a nerve located in this area, or referred to a dermatome.
- Secondary Outcome Measures
Name Time Method Pre operative factors 60 to 1 day before the scheduled procedure * Age
* 18-35
* 36-55
* ≥55
* Sex
* Female
* Male
* BMI
* ≤18.5 - 24.9
* 25 - 29.9
* ≥30
* Alcohol or substances of abuse (Y/N) (specify the substance)
* Previous experience of pain NRS ≥5 for 7 days (Y/N)
* Presence of chronic pathologies (Y/N) (if yes, provide the list of medications)
* Pharmacological treatments including supplements or nutraceuticals (continuous in the last 3 months) (Y/N) (if yes, provide the list of drugs)
* Chronic pain (NRS ≥3 for ≥3 months) (Y/N)
* Neuropathic pain (Y/N) (assessment using Douleur Neuropathique en 4 questions DN-4 questionnaire)
* Pain catastrophizing (Y/N) (assessment via Pain Catastrophizing Scale PCS questionnaire)
* Anxiety (Y/N) (assessment using General Anxiety Disorder-7 GAD-7 questionnaire)
* Depression (Y/N) (assessment using Beck Depression Inventory BDI-II questionnaire)
* Presence of pain in the last three days (NRS ≥3 mean pain intensity in the 24 hours) (Y/N)Perioperative factors - before surgery The day of the scheduled surgery - before the surgery * Site of surgery
* Head
* Vertebral column
* Arms/legs
* Chest
* Abdomen
* Genitourinary system
* Surgical technique
* Open surgery
* Minimally invasive surgery
* Robotic surgery
* ERAS (enhanced recovery after surgery) protocol (Y/N)
* Anesthesiologic technique
* General Anesthesia
* Spinal Anesthesia
* Epidural Anesthesia
* Peripheral nerve block
* Preventive/protective analgesia (Y/N)
* Premedication (Y/N)
* OFA opioid-free anesthesia protocol (Y/N)
* Postoperative analgesic prescription (Y/N)Post operative factors 3 months after surgery * Pain assessment: average pain intensity assessed using a standard NRS scale (the cutoff score will be set at ≥3 mean pain intensity over the last three days ) (Y/N).
* Diagnosis of CPSP (the pain is localized in the surgical field or in the area of the lesion, projected into the innervation territory of a nerve located in this area, or referred to a dermatome) (Y/N)
* Surgical complications (Y/N)
* Infectious complications related to surgery (Y/N)
* Malignancy (Y/N)
* Neuropathic pain (Y/N) (assessed using Douleur Neuropathique in 4 questions DN-4 questionnaire)Perioperative factors - after surgery Immediately after the surgery to 48 hours after the surgery * Pain NRS score ≥3 at the end of the surgery (Y/N)
* Presence of pain (NRS ≥5 - average value in the 24 hours) in the region of the operation at rest or during movement after surgery (Y/N)
* Analgesic prescription after surgery
* ≤12 hours of coverage
* 13-24 hours of coverage
* ≥ 24 hours of coverage
* Postoperative surgical complications (Y/N)
* Postoperative infectious complications (Y/N)
* Mobilization after surgery ≤6 hours? (Y/N)
Trial Locations
- Locations (1)
AOU G. Martino
🇮🇹Messina, Italy