Chronic Postsurgical Pain: Multivariate Prediction Model

Post Operative Pain Clinical Trial

— CPoP  

Official title:

Chronic Postsurgical Pain: Multivariate Prediction Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417528
• Other study ID #: CPoP
• Status: Recruiting
• Start date: December 14, 2022
• Est. completion date: June 14, 2025

Study information

• Verified date: May 2024
• Source: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
• Contact: Luigi Cardia, MD; PhD
• Phone: +39 340 6946866
• Email: lcardia[@]unime.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 14, 2025
• Est. primary completion date: December 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult Patients

• Patients undergoing any type of elective surgery

Exclusion Criteria:

• Patients with sensory impairments

• Patients unable to communicate

• Patients with cognitive impairments

• Patients with insufficent knowledge of the language

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Postoperative
• Post Operative Pain
• Post Surgical Pain

Intervention

Procedure:
• Chronic Post Surgery Pain (CPSP)
The outcome variable is the presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 on the NRS scale (11-point one-dimensional pain scale) 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. Separate prediction models will be developed using data derived from surveys conducted at the relevant time points for the development of the risk index.

Locations

Country	Name	City	State
Italy	AOU G. Martino	Messina

Sponsors (1)

Lead Sponsor	Collaborator
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Country where clinical trial is conducted

Italy, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Development of the risk index	Primary version of the risk index, made up of items derived from a systematic bibliographic search (compilation of the item pool).; Authors will analyze the associations between each of these indices and the probability of CPSP 3 months after surgery (dichotomous variable), evaluated using logistic regression models.; Items that were found to be significant in the bivariate analyses will then be analyzed multivariately (logistic regression models).; Authors will safeguard the results of the multivariate analyses by calculating the area under the ROC curve of the model, and then, the cut-off score for a high risk of developing CPSP will be identified with an optimal compromise between sensitivity and specificity.; The items that will generate significant predictive factors in the logistic regression analyses will be collected into an index. For each value of this index, the Authors will calculate the proportion of patients who reported CPSP at 3 months after surgery.	6 months after the primary completion of the study
Primary	Chronic Post Surgery Pain (CPSP)	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.	3 months
Secondary	Pre operative factors	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)	60 to 1 day before the scheduled procedure
Secondary	Perioperative factors - before 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)	The day of the scheduled surgery - before the surgery
Secondary	Perioperative factors - after 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)	Immediately after the surgery to 48 hours after the surgery
Secondary	Post operative factors	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)	3 months after surgery