Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.

Knee Osteoarthritis Clinical Trial

Official title:

Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01811888
• Other study ID #: TKAPAIN
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2013
• Last updated: October 21, 2015
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Parc de Salut Mar
• Contact: Dürsteler Christian, PhD
• Phone: 0034932483350
• Email: cdursteler[@]parcdesalutmar.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 177
• Est. completion date: December 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Older than 18 patients

• Scheduled for primary total knee arthroplasty

• Disposition to visits and scheduled tests

Exclusion Criteria:

• Previous surgery on knee to be operated

• Documented peripheral neuropathy

• Severe disease or condition that could potentially interfere with interpretation of tests.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Quantitative sensory testing (QST)

Locations

Country	Name	City	State
Spain	Servicio d'Anestesia i Reanimació, Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of pain in the operated knee, 6 months after surgery.		Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.	Yes
Secondary	Endogenous Analgesia efficiency measured with QST (Quantitative sensory testing) techniques.		From start of recruitment untill day 180.	No