NCT03450681

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

February 23, 2018

Last Update Submit

March 2, 2018

Conditions

ArthroplastyReplacementKneePain

Keywords

Pain ManagementKnee Replacement ArthroplastyPostoperative PainPulsed Radiofrequency Treatment

Outcome Measures

Primary Outcomes (1)

  • Pain 6 months after sugery

    VAS Pain value 6 months after the knee replacement surgery. The Visual Analog Scale to assess pain ranges from 0mm to 100mm, where 0 is the 'absence of pain' and 100 is 'the worst pain imaginable by the patient'. Lower values in the scale represent a better outcome for the patient.

    6 months

Secondary Outcomes (4)

  • Opioid consumption during the postoperative period

    3 days

  • Pain on postoperative days 0-3

    3 days

  • Pain on postoperative week 2

    15 days

  • Pain on postoperative month 2

    2 months

Study Arms (2)

No pulsed radiofrequency

PLACEBO COMPARATOR

Procedure consists of a mock incision at the pulsed radiofrequency needle insertion site and standard perioperative pain management by the pain clinic (femoral catheter and PCA)

Procedure: Mock incision

Pulsed Radiofrequency

EXPERIMENTAL

Procedure consists in pre-operative pulsed radiofrequency under ultrasound guidance of the saphenous nerve and standard postoperative pain management by the pain clinic (femoral catheter and PCA)

Procedure: Pulsed radiofrequency of the saphenous nerve before knee replacement surgery

Interventions

Pulsed radiofrequency of the saphenous nerve before knee replacement surgeryPROCEDURE

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.

Pulsed Radiofrequency
Mock incisionPROCEDURE

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

No pulsed radiofrequency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients from the Center for Care of Articular Replacements from Fundación Santa Fe University Hospital programed for knee replacement surgery.
  • ASA I-III
  • Informed consent
  • Unilateral Knee Replacement

You may not qualify if:

  • Neurologic conditions associated with hyperalgesia or allodynia
  • Cognitive impairment
  • Psychiatric conditions
  • Contraindication for the use of local anesthetics
  • Bleeding disorders
  • Pacemaker or ICD
  • Septic arthritis or any infection in the surgical site
  • Additional surgical procedure during the surgical act

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainAgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiologist specialist in pain management

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

November 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2017

Last Updated

March 6, 2018

Record last verified: 2018-03