Sensory alterations and immunological changes during the chronification of postsurgical pain

Sensory alterations and immunological changes during the chronification of postsurgical pain - SCIP-Pain

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54335

Enrollment

150

Registered

2021-04-28

Start date

2021-09-15

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperatieve pijn Chronic postsurgical pain (CPSP) chronic pain after surgery

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Contacts

Public ContactM. Rijsdijk

Universitair Medisch Centrum Utrecht

pijnsecretariaat@umcutrecht.nl0887556163

Outcome results