Assessment of the Development of Postoperative Persistent Postoperative Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05370924
• Other study ID #: DOROTHEA
• Status: Recruiting
• Start date: February 20, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Maurizio Berardino
• Phone: +390116331633
• Email: mberardino[@]cittadellasalute.to.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use
• Pain, Postoperative
• Post Operative Pain

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza di Torino - Presidio ospedaliero CTO	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent and chronic postsurgical pain	Presence or not of posturgical pain, persistent NRS > 4 in surgical area	48 hrs, 2 weeks, 3 months
Secondary	NRS	pain	3 months
Secondary	Postsurgical complications	Presence y/n of surgical complications	3 months
Secondary	Anxiety	Psychometric test, GAD-7	3 months
Secondary	Depression	Psychometric test, PHQ-9	3 months