Cartography of Allodynic and Hypoasthetic Territories Following TKA

Pain, Postoperative Clinical Trial

— CARTODOL  

Official title:

Cartography of Allodynic and Hypoasthetic Territories Associated With Neuropathic Pain Following Total Knee Arthroplasty (TKA)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02828800
• Other study ID #: PI2015_843_0034
• Status: Terminated
• Start date: July 12, 2016
• Est. completion date: February 18, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to realize a cartography of the allodynic and hypoasthetic territories associated with a neuropathic pain appearing in patients who underwent a Total Knee Arthroplasty (TKA)

Description:

The occurrence of Post-surgical Pain depends on the surgical procedure performed, the surgical site and patients-dependents characteristics. Post surgical pain became chronic when it persist beyond two month.

Chronic post-surgical pain (CPSP) is one of the most common complications after surgery. Nerve injury during surgery has been implicated in the development of CPSP. Some patients with CPSP have neuropathic pain (NP). NP is pain cause by damage or disease affecting the somatosensory nervous system. It may be associated with abnormal cutaneous sensation such as hypoesthesia (partial loss of sensitivity to sensory stimuli) or allodynia (pain from normally non-painful stimuli)

Total Knee Arthroplasty (TKA) present a high risk of injury of the infrapatellar branch of the saphenous nerve, thus can cause the appearance of neuropathic post-surgical pain. Only few data are available concerning the skin areas affected after this surgery.

The goal of this study is to analyse the localization of allodynic or hypoasthetic territories that may appear after TKA. The investigators will include 200 patients undergoing TKA surgery at the CHU-Amiens-Picardie. Patient will be seen the day before their surgery, and at follow-up visits at 6 weeks, 6 months and one year postoperatively. A DN diagnostic test (DN4 test) will be performed at each visits. The cartography will be performed on each DN4-positive patients. In addition, patients will also complete questionnaires to assess the intensity of pain, quality of life and level of anxiety.

Thus, the knowledge of the localization of allodynic or hypoasthetic territories will allow a most efficient an faster detection and relief of post-surgical neuropathic pain.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: February 18, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• major patient benefit from a first setting operation of TKA (total knee arthroplasty) by standard medial arthrotomy

• Patient signed an informed consent

• Patients receiving social coverage

Exclusion Criteria:

• Patient not wishing to be part of the study, or unable to consent,

• Patient under guardianship or deprived of his liberty

• Patients with neuropathic pain in the territory concerned preoperatively

• Patient who underwent TKA laying by a technique other than standard medial arthrotomy

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Pain, Postoperative

Intervention

Other:
• Cartography of allodynic and hypoasthetic territories
The cartography of allodynic and hypoasthetic territories will be performed by applying a tactile stimulation of an application force of 15g (for allodynia) or 0.7g (for hypoesthesia). Tracings will be plotted on tracing paper layer that will then be evaluated by the VISITRAK® tool (Smith & Nephew), validated method reproducible and standardized, enabling accurate measurement of the area concerned .

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cartography of allodynic and hypoasthetic territories	The cartography of allodynic and hypoasthetic territories will be performed by applying a tactile stimulation of an application force of 15g (for allodynia) or 0.7g (for hypoesthesia). Tracings will be plotted on tracing paper layer that will then be evaluated by the VISITRAK® tool (Smith & Nephew), validated method reproducible and standardized, enabling accurate measurement of the area concerned .	week 6