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Clinical Trials/NCT05370924
NCT05370924
Recruiting
Not Applicable

Assessment and Risk Stratification of the Development of Postoperative Persistent Postoperative Pain in Patients Undergoing Orthopedic Surgery

A.O.U. Città della Salute e della Scienza1 site in 1 country600 target enrollmentFebruary 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use
Sponsor
A.O.U. Città della Salute e della Scienza
Enrollment
600
Locations
1
Primary Endpoint
Persistent and chronic postsurgical pain
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

During the postoperative period, it is possible to observe the development of acute pain, which lasts no longer than a week after surgery. However, sometimes some patients see the prolongation of this pain beyond the healing time of the tissue, turning into a chronic condition. Persistent postoperative pain is a disease with a complex and still unknown etiology, affecting between 5 and 75% of the population. The development of persistent postoperative pain is a rather important issue since the physician managing the patient must on the one hand ensure adequate analgesia, and on the other hand, minimize the risk of continued opioid use in the case of chronicization.

In a study conducted analyzing the prevalence of persistent postoperative pain in various surgeries it was seen to occur more frequently in limb amputation (prevalence >85%), thoracotomy (prevalence 48%), knee arthroplasty (prevalence 44%), laminectomies, and spinal arthrodesis (prevalence 5-46%), and hip replacement (prevalence 27%) making this type of pain more frequent in the patient undergoing orthopedic surgery.

As the mechanisms behind its development have not yet been fully clarified, efforts to study the clinical factors associated with the onset of this pathology have been attempted.

As there is no way in the literature to stratify the risk of the population in order to prevent the development of postoperative pain, based on the variables reported by different studies, it was decided to administer in patients referred to the Orthopedics and Traumatology 1 U and Orthopedics and Traumatology 3 U department at the Orthopedic Trauma Center of Turin questionnaires to assess the development of chronic pain for screening purposes and to contribute to the improvement of the long-term management of these patients in the postoperative period.

Registry
clinicaltrials.gov
Start Date
February 20, 2021
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
A.O.U. Città della Salute e della Scienza
Responsible Party
Principal Investigator
Principal Investigator

Maurizio Berardino

Director

A.O.U. Città della Salute e della Scienza

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing orthopedic surgery considered at high risk of developing persistent postoperative pain (i.e. knee prothesic surgery, hip prothesic surgery, spine fusion surgery)

Exclusion Criteria

  • Patients undergoing redo prothesic surgery
  • Trauma patients

Outcomes

Primary Outcomes

Persistent and chronic postsurgical pain

Time Frame: 48 hrs, 2 weeks, 3 months

Presence or not of posturgical pain, persistent NRS \> 4 in surgical area

Secondary Outcomes

  • Anxiety(3 months)
  • NRS(3 months)
  • Postsurgical complications(3 months)
  • Depression(3 months)

Study Sites (1)

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