Assessment of the Development of Postoperative Persistent Postoperative Pain

Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)
Overall Status
Recruiting ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Assessment and Risk Stratification of the Development of Postoperative Persistent Postoperative Pain in Patients Undergoing Orthopedic Surgery
    Actual Study Start Date :
    Feb 20, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. NRS [3 months]


    2. Postsurgical complications [3 months]

      Presence y/n of surgical complications

    3. Anxiety [3 months]

      Psychometric test, GAD-7

    4. Depression [3 months]

      Psychometric test, PHQ-9

    Eligibility Criteria


    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 AOU Città della Salute e della Scienza di Torino - Presidio ospedaliero CTO Torino Italy 10126

    Sponsors and Collaborators

    • Azienda Ospedaliera Città della Salute e della Scienza di Torino


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Maurizio Berardino, Director, Azienda Ospedaliera Città della Salute e della Scienza di Torino Identifier:
    Other Study ID Numbers:
    First Posted:
    May 12, 2022
    Last Update Posted:
    May 12, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Maurizio Berardino, Director, Azienda Ospedaliera Città della Salute e della Scienza di Torino
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 12, 2022