Pain Clinical Trial
Official title:
Efectividad de la Radiofrecuencia Pulsada Del Nervio Safeno en el Manejo Del Dolor en Artroplastia de Rodilla
Verified date | March 2018 |
Source | Fundación Santa Fe de Bogota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 111 |
Est. completion date | June 2017 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fundación Santa Fe de Bogota |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Opioid consumption during the postoperative period | PCA opioid consumption during postoperative days 0 - 3 in morphine equivalents | 3 days | |
Secondary | Pain on postoperative days 0-3 | VAS Pain value on day 0, 1, 2 and 3 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. | 3 days | |
Secondary | Pain on postoperative week 2 | VAS Pain value on day 15 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. | 15 days | |
Secondary | Pain on postoperative month 2 | VAS Pain value 2 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. | 2 months |
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