Assessment of the Development of Postoperative Persistent Postoperative Pain

Recruiting

• Conditions: Opioid Use; Post Operative Pain; Chronic Pain

• Registration Number: NCT05370924
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-20
• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-05-07
• Study First Posted: 2022-05-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Persistent and chronic postsurgical pain	48 hrs, 2 weeks, 3 months	Presence or not of posturgical pain, persistent NRS \> 4 in surgical area

Secondary Outcome Measures

Name	Time	Method
Anxiety	3 months	Psychometric test, GAD-7
NRS	3 months	pain
Postsurgical complications	3 months	Presence y/n of surgical complications
Depression	3 months	Psychometric test, PHQ-9

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza di Torino - Presidio ospedaliero CTO; 🇮🇹 Torino, Italy