ArthroplastyNCT03450681
Effectiveness of Pulsed Radiofrequency of the Saphenous Nerve in the Management of Knee Arthroplasty Pain
A study testing Pulsed radiofrequency of the saphenous nerve before knee replacement surgery and Mock incision in people with Arthroplasty and Replacement, run by Fundación Santa Fe de Bogota.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Pulsed radiofrequency of the saphenous nerve before knee replacement surgery and Mock incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Efectividad de la Radiofrecuencia Pulsada Del Nervio Safeno en el Manejo Del Dolor en Artroplastia de Rodilla
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.
Read the detailed description
Methods
Study Design
Randomized, blinded clinical trial. Patients are divided into two groups, one to saphenous nerve block with pulsed radiofrequency guided by ultrasound is applied plus standard pain management by the Pain Clinic, the other one only standard pain management by the Pain Clinic. A 6-month follow-up is evaluating pain by VAS and function by the WOMAC scale
Objectif
Asses the effectivity and safety of preoperatory saphenous nerve pulsed radiofrecuency in total knee arthroplasty between 2014 and 2015 in the Fundación Santa Fe de Bogotá Hospital.
Statistical Analysis
Sample size was calculated using "Sample Size 1.0". The following parameters where used to calculate the sample size for a clinical trial:
Two tails, type I error independent variables 5%, type II error 20%, outcome variable: visual analogue scale from 0 to 100 mm, with a standard deviation of 10 mm and a relevant clinical difference between groups of 20 mm. Additionally, the WOMAC scale, from 0 to 96 points, with a standard deviation of 17 and a relevant clinical difference of 20 points between groups for the three subscales: pain, rigidity and functional capacity, normalized to 100 points each.
A sample size of 41 patients per group is calculated. An adjustment of 20% to compensate possible losses is applied, to a total of 50 patients per group.
Once gathered, the data is processed using the statistical program "Wizard" version 1.7.17. posteriorly, variables are standardized and a descriptive analysis is performed.
Central tendency and dispersion measures are performed to the continuous variables. Percentage distribution and proportion measures are calculated to the categorical variables.
- Conditions
- Arthroplasty, Replacement, Knee, Pain
- Being tested
- Pulsed radiofrequency of the saphenous nerve before knee replacement surgery, Mock incision
- Keywords
- Pain Management, Knee Replacement Arthroplasty, Postoperative Pain, Pulsed Radiofrequency Treatment
- Medical subject headings
- Pain, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed radiofrequency of the saphenous nerve before knee replacement surgeryProcedure or 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.
Mock incisionProcedure or surgery
A trained anesthesiologist and pain clinician performs a mock incision on the pulsed radiofrequency needle insertion site
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Pulsed radiofrequency of the saphenous nerve before knee replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Opioid consumption during the postoperative period
PCA opioid consumption during postoperative days 0 - 3 in morphine equivalents
Measured: 3 days
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.
Measured: 3 days
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.
Measured: 15 days
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study startNov 2014
- Primary completionJun 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Guerrero Nope, Fundación Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450681
- Sponsor's protocol ID
- CCEI-2214-2014
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2018
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efectividad de la Radiofrecuencia Pulsada Del Nervio Safeno en el Manejo Del Dolor en Artroplastia de Rodilla
- ClinicalTrials.gov ID
- NCT03450681
- Acronym / sponsor ID
- CCEI-2214-2014
- Conditions
- Arthroplasty, Replacement, Knee, Pain
- Keywords
- Pain Management, Knee Replacement Arthroplasty, Postoperative Pain, Pulsed Radiofrequency Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methods
Study Design
Randomized, blinded clinical trial. Patients are divided into two groups, one to saphenous nerve block with pulsed radiofrequency guided by ultrasound is applied plus standard pain management by the Pain Clinic, the other one only standard pain management by the Pain Clinic. A 6-month follow-up is evaluating pain by VAS and function by the WOMAC scale
Objectif
Asses the effectivity and safety of preoperatory saphenous nerve pulsed radiofrecuency in total knee arthroplasty between 2014 and 2015 in the Fundación Santa Fe de Bogotá Hospital.
Statistical Analysis
Sample size was calculated using "Sample Size 1.0". The following parameters where used to calculate the sample size for a clinical trial:
Two tails, type I error independent variables 5%, type II error 20%, outcome variable: visual analogue scale from 0 to 100 mm, with a standard deviation of 10 mm and a relevant clinical difference between groups of 20 mm. Additionally, the WOMAC scale, from 0 to 96 points, with a standard deviation of 17 and a relevant clinical difference of 20 points between groups for the three subscales: pain, rigidity and functional capacity, normalized to 100 points each.
A sample size of 41 patients per group is calculated. An adjustment of 20% to compensate possible losses is applied, to a total of 50 patients per group.
Once gathered, the data is processed using the statistical program "Wizard" version 1.7.17. posteriorly, variables are standardized and a descriptive analysis is performed.
Central tendency and dispersion measures are performed to the continuous variables. Percentage distribution and proportion measures are calculated to the categorical variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No pulsed radiofrequency | Placebo comparator | Procedure: Mock incisionProcedure 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) |
| Pulsed Radiofrequency | Experimental | Procedure: Pulsed radiofrequency of the saphenous nerve before knee replacement surgeryProcedure 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Neurologic conditions associated with hyperalgesia or allodynia
- Cognitive impairment
- Psychiatric conditions
- Contraindication for the use of local anesthetics
- Bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed radiofrequency of the saphenous nerve before knee replacement surgeryA 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 or surgery | Pulsed Radiofrequency |
| Mock incisionA trained anesthesiologist and pain clinician performs a mock incision on the pulsed radiofrequency needle insertion site | Procedure or surgery | No pulsed radiofrequency |
Primary outcome
Pain 6 months after sugery
Time frame: 6 months
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.
4 secondary outcomes
Opioid consumption during the postoperative period
Time frame: 3 days
Pain on postoperative days 0-3
Time frame: 3 days
Pain on postoperative week 2
Time frame: 15 days
Pain on postoperative month 2
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed radiofrequency of the saphenous nerve before knee replacement surgery and Mock incision in people with Arthroplasty and Replacement, run by Fundación Santa Fe de Bogota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain 6 months after sugery (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.