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Effectiveness of Pulsed Radiofrequency of the Saphenous Nerve in the Management of Knee Arthroplasty Pain

NCT03450681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2018-03-06

No results posted yet for this study

Summary

Approximately 40% of patients undergoing total knee arthroplasty develop acute to moderate post operative pain. Furthermore 20-30% develop chronic post operative pain. The objective of this work is to study the effectiveness and safety of pulsed radiofrequency of the saphenous nerve realized during the pre-operative period of total knee arthroplasty. The study design is a randomized, blinded clinical trial. Patients scheduled for total knee arthroplasty are divided into two groups. The first group procedure consists in pre-operative pulsed radiofrequency under ultrasound guidance of the saphenous nerve and standard postoperative pain management by the pain clinic. The second group receives only the standard postoperative pain management by the pain clinic. Patient follow ups are performed 3 times (after 2 weeks, 2 months and 6 months) within a period of 6 months, evaluating pain severity using the VAS.

Conditions

  • Arthroplasty
  • Replacement
  • Knee
  • Pain

Interventions

PROCEDURE

Pulsed radiofrequency of the saphenous nerve before knee replacement surgery

A trained anesthesiologist and pain clinician performs ultrasound guided pulsed radiofrequency on the saphenous nerve of a patient undergoing knee replacement surgery, prior to the beginning of the surgical act.

PROCEDURE

Mock incision

A trained anesthesiologist and pain clinician performs a mock incision on the pulsed radiofrequency needle insertion site

Sponsors & Collaborators

  • Fundación Santa Fe de Bogota

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-06-30
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450681 on ClinicalTrials.gov