NCT05370924

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3.4 years

First QC Date

February 2, 2022

Last Update Submit

February 5, 2024

Conditions

Opioid UsePost Operative PainChronic Pain

Keywords

postoperative painopioid naiveopioid tolerantorthopedic surgery

Outcome Measures

Primary Outcomes (1)

  • Persistent and chronic postsurgical pain

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

    48 hrs, 2 weeks, 3 months

Secondary Outcomes (4)

  • NRS

    3 months

  • Postsurgical complications

    3 months

  • Anxiety

    3 months

  • Depression

    3 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients undergoing redo prothesic surgery
  • Trauma patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza di Torino - Presidio ospedaliero CTO

Torino, 10126, Italy

RECRUITING

Related Publications (3)

  • Steyaert A, Lavand'homme P. Prevention and Treatment of Chronic Postsurgical Pain: A Narrative Review. Drugs. 2018 Mar;78(3):339-354. doi: 10.1007/s40265-018-0866-x.

    PMID: 29380289BACKGROUND

  • Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6.

    PMID: 30983589BACKGROUND

  • Tiippana E, Hamunen K, Heiskanen T, Nieminen T, Kalso E, Kontinen VK. New approach for treatment of prolonged postoperative pain: APS Out-Patient Clinic. Scand J Pain. 2016 Jul;12:19-24. doi: 10.1016/j.sjpain.2016.02.008. Epub 2016 Mar 11.

    PMID: 28850486BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Maurizio Berardino

CONTACT

+390116331633mberardino@cittadellasalute.to.it

Doriana Dongu, MD

CONTACT

+3390116331633ddongu@cittadellasalute.to.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 2, 2022

First Posted

May 12, 2022

Study Start

February 20, 2021

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

IT(1)