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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery Patients | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chronic Post Surgery Pain (CPSP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pre operative factors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of the risk index |
|
Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing any type of elective surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Cardia, MD; PhD | Contact | +39 340 6946866 | lcardia@unime.it | |
| Alberto Noto, MD; PhD | Contact | alberto.noto@unime.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU G. Martino | Recruiting | Messina | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25844555 | Background | Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available. | |
| 16698416 |
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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 | Nov 2, 2023 | Mar 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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|
| 60 to 1 day before the scheduled procedure |
| Perioperative factors - before surgery |
| The day of the scheduled surgery - before the surgery |
| Perioperative factors - after surgery |
| Immediately after the surgery to 48 hours after the surgery |
| Post operative factors |
| 3 months after surgery |
| 6 months after the primary completion of the study |
| Background |
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| D012816 | Signs and Symptoms |