Assessment of the Development of Postoperative Persistent Postoperative Pain

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Maurizio Berardino; Phone Number: +390116331633; Email: mberardino@cittadellasalute.to.it
• Study Contact Backup: Name: Doriana Dongu, MD; Phone Number: +3390116331633; Email: ddongu@cittadellasalute.to.it

Study Locations

• Italy
  • Torino, Italy, 10126
    • Recruiting
    • AOU Città della Salute e della Scienza di Torino - Presidio ospedaliero CTO
    • Contact: Maurizio Berardino
    • Principal Investigator: Doriana Dongu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistent and chronic postsurgical pain	Presence or not of posturgical pain, persistent NRS > 4 in surgical area	48 hrs, 2 weeks, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS	pain	3 months
Postsurgical complications	Presence y/n of surgical complications	3 months
Anxiety	Psychometric test, GAD-7	3 months
Depression	Psychometric test, PHQ-9	3 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: May 7, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain; orthopedic surgery; opioid naive; opioid tolerant
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: DOROTHEA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No