Sensory alterations and immunological changes during the chronification of postsurgical pai

Recruiting

Conditions: Postoperatieve pijn
Chronic postsurgical pain (CPSP)

Registration Number: NL-OMON54335

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Aged 18 years or older;
- Scheduled for elective orthopedic surgery on lower extremities;
- Able and willing to give written informed consent.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Major cognitive or psychiatric disorders, because QST involves the full
co-operation of participants.
- Problems with communication (language, deafness, aphasia etc.).
- Acute infection confirmed by clinical, laboratory and standard radiological
examination, which could confound the assessment of the immunological response.
- Pre-operative definite neuropathic pain condition in the lower extremities
according to the updated grading system for neuropathic pain in research and
clinical practice by Finnerup et al. in patients scheduled for elective
orthopedic surgery of lower extremities, which could confound the assessment of
pain processing in the perioperative period.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study outcome of interest is the presence of pain with neuropathic<br /><br>characteristics within three months after surgery as assessed by a numerical<br /><br>rating scale (NRS) of 4 or above and a Douleur Neuropathique en 4 (DN4) at a<br /><br>previously defined cutoff score of 4 or higher. Before an endpoint was<br /><br>registered, the presence or absence of pain with neuropathic characteristics<br /><br>must be adjudicated by a consulting pain specialist. The conclusion by the pain<br /><br>specialist whether pain has neuropathic characteristics is regarded as the gold<br /><br>standard. </p><br>

Secondary Outcome Measures