Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619080
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Ecoguided Genicular Nerve Block
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ecoguided Genicular Nerve Block in Patients with Knee Osteoarthritis by Local Anesthetic or by Combination of Local Anesthetic and Corticoid Placebo-Controlled Randomized Blind Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoarthritis is a pathology with high prevalence in the world and is increasing due to sedentary lifestyles Recent researches that claim for conservative treatment have shown the utility of genicular nerve blocks for relief of chronic knee pain
Likewise the ultrasound-guided technique has been more popular among professionals in recent years due to its low cost and safety
This pilot study tries to evaluate if the infiltration of local anesthetic could avoid the use of corticosteroids with the secondary effects that they entail therefore it is carried out with the intention of estimating the size of the effect and the use of the variable response for later carrying out a clinical trial
For this we propose the comparative analysis of three randomized groups of patients n90 where all of them will perform a quadriceps strengthening exercise at home Moreover we will assess the reduction of pain through the visual analog scale VAS after the genicular nerve block with ultrasound-guided infiltration Group 1 n30 will be infiltrated with local anesthetic and steroid group 2 n30 with local anesthetic and group 3 n30 as a control group will receive physiological saline We will also record demographic data functionality and mood using validated scales
Likewise the ultrasound-guided technique has been more popular among professionals in recent years due to its low cost and safety
This pilot study tries to evaluate if the infiltration of local anesthetic could avoid the use of corticosteroids with the secondary effects that they entail therefore it is carried out with the intention of estimating the size of the effect and the use of the variable response for later carrying out a clinical trial
For this we propose the comparative analysis of three randomized groups of patients n90 where all of them will perform a quadriceps strengthening exercise at home Moreover we will assess the reduction of pain through the visual analog scale VAS after the genicular nerve block with ultrasound-guided infiltration Group 1 n30 will be infiltrated with local anesthetic and steroid group 2 n30 with local anesthetic and group 3 n30 as a control group will receive physiological saline We will also record demographic data functionality and mood using validated scales
Detailed Description:
Osteoarthritis affects approximately 302 million people worldwide with the knee hip and hands being the most commonly affected areas Knee osteoarthritis is highly prevalent and increasing in the region due to aging obesity and the progressive sedentary lifestyle of the population According to recent epidemiological studies it has a prevalence of 293 in the Spanish population
Currently multiple treatment options are available ranging from conservative measures to surgical procedures Within conservative treatment various tools benefit patients and may even avoid the need for surgery These non-surgical options include patient education weight control physical exercise orthotics oral analgesics topical anti-inflammatories and interventional procedures However there are no prior studies demonstrating the advantages of one over another and many do not follow up beyond three months
When conservative treatment is ineffective surgical intervention is usually considered Therapeutic options include knee arthroscopy high tibial osteotomy total knee replacement and unicompartmental knee replacement in patients without lateral compartment disease
Traditionally rest and caution in exercise were recommended for knee osteoarthritis pain However this paradigm has been strongly rejected One of the current first-line treatments for knee osteoarthritis is physical exercise with quadriceps strengthening being the most indicated Most patients seek recommendations on what type of exercise to perform including the duration intensity and frequency for better adherence No exercise has been shown to be superior to another with the most studied being yoga and tai chi exercises
Despite the well-documented benefits of exercise for this condition one emerging procedure for pain management is the genicular nerve block This treatment option can facilitate progress in the exercise program It is also indicated for patients who have previously had successful genicular block those who do not wish to undergo surgery those not eligible for surgery or even post-surgical patients for better pain control
The term 34genicular nerves34 refers to a group of nerves responsible for the sensory innervation of the knee joint capsule and the internal and external ligaments The superior and inferior medial genicular nerves are sensory branches of the tibial nerve whereas the superior and inferior lateral genicular nerves are branches of the common peroneal nerve These nerves are named after the arteries they accompany which are located using ultrasound during the procedure
Genicular nerve block is a simple technique that significantly reduces opioid consumption in patients undergoing total knee arthroplasty within the first 24 hours It also provides temporary relief that allows progression in the rehabilitation program through a structured exercise regimen This technique involves injecting medication into the genicular nerves locating the genicular artery using Doppler ultrasound Various cadaveric studies have investigated the anatomical distribution of the descending genicular artery and the nerves accompanying its branches
Some authors suggest that up to 10 points may need to be blocked for complete coverage However this is not feasible in routine clinical practice Most studies target three sensory nerves of the knee the superior lateral genicular nerve the superior medial genicular nerve and the inferior medial genicular nerve In most studies 2 to 3 ml of local anesthetic is administered per point It has been shown that 05 ml of injected fluid spreads within the tissue over an area of 6 cm² likely covering more nerve targets with 2 ml Typically the procedure involves infiltrating local anesthetic lidocaine bupivacaine ropivacaine levobupivacaine and 20 mg of corticosteroid triamcinolone
In this study bupivacaine is chosen as the local anesthetic as it inhibits prostaglandin production by binding to the E2 receptor providing an anti-inflammatory effect It is a lipophilic amide-type anesthetic with 100 bioavailability and a longer duration than other local anesthetics Additionally it produces a more significant blockade of sensory and sympathetic nerve fibers than motor fibers differentiating it from other local anesthetics
Recent guidelines for the treatment of knee osteoarthritis highlight the recommendation of intra-articular corticosteroid injections However several studies mention that systemic and local corticosteroid effects can cause adverse effects such as skin atrophy hypertension insulin resistance decreased bone mineralization and septic arthritis among others Nonetheless these effects have not demonstrated a direct relationship with pain functionality or radiological changes
The clinical benefit of corticosteroid administration compared to local anesthesia alone remains unclear Given the potential adverse effects corticosteroids may not be suitable as adjuvants Therefore genicular nerve block using local anesthetic alone proves to be a promising technique avoiding the use of corticosteroids and not being an intra-articular procedure
A study is proposed at a tertiary hospital in the Community of Madrid Hospital Universitario Fundación Alcorcón Considering the absence of previous studies that evaluate and quantify the three described treatment options this study aims to address this objective through a pilot experimental randomized controlled trial All patients will receive guidelines for an exercise program and the outcomes of adding genicular nerve block with and without corticosteroid will be assessed This unprecedented study could identify the optimal treatment for this prevalent and debilitating condition in a significant portion of the population Additionally it will help optimize resource allocation for these patients by identifying the best therapeutic target thus avoiding unnecessary resource consumption
Currently multiple treatment options are available ranging from conservative measures to surgical procedures Within conservative treatment various tools benefit patients and may even avoid the need for surgery These non-surgical options include patient education weight control physical exercise orthotics oral analgesics topical anti-inflammatories and interventional procedures However there are no prior studies demonstrating the advantages of one over another and many do not follow up beyond three months
When conservative treatment is ineffective surgical intervention is usually considered Therapeutic options include knee arthroscopy high tibial osteotomy total knee replacement and unicompartmental knee replacement in patients without lateral compartment disease
Traditionally rest and caution in exercise were recommended for knee osteoarthritis pain However this paradigm has been strongly rejected One of the current first-line treatments for knee osteoarthritis is physical exercise with quadriceps strengthening being the most indicated Most patients seek recommendations on what type of exercise to perform including the duration intensity and frequency for better adherence No exercise has been shown to be superior to another with the most studied being yoga and tai chi exercises
Despite the well-documented benefits of exercise for this condition one emerging procedure for pain management is the genicular nerve block This treatment option can facilitate progress in the exercise program It is also indicated for patients who have previously had successful genicular block those who do not wish to undergo surgery those not eligible for surgery or even post-surgical patients for better pain control
The term 34genicular nerves34 refers to a group of nerves responsible for the sensory innervation of the knee joint capsule and the internal and external ligaments The superior and inferior medial genicular nerves are sensory branches of the tibial nerve whereas the superior and inferior lateral genicular nerves are branches of the common peroneal nerve These nerves are named after the arteries they accompany which are located using ultrasound during the procedure
Genicular nerve block is a simple technique that significantly reduces opioid consumption in patients undergoing total knee arthroplasty within the first 24 hours It also provides temporary relief that allows progression in the rehabilitation program through a structured exercise regimen This technique involves injecting medication into the genicular nerves locating the genicular artery using Doppler ultrasound Various cadaveric studies have investigated the anatomical distribution of the descending genicular artery and the nerves accompanying its branches
Some authors suggest that up to 10 points may need to be blocked for complete coverage However this is not feasible in routine clinical practice Most studies target three sensory nerves of the knee the superior lateral genicular nerve the superior medial genicular nerve and the inferior medial genicular nerve In most studies 2 to 3 ml of local anesthetic is administered per point It has been shown that 05 ml of injected fluid spreads within the tissue over an area of 6 cm² likely covering more nerve targets with 2 ml Typically the procedure involves infiltrating local anesthetic lidocaine bupivacaine ropivacaine levobupivacaine and 20 mg of corticosteroid triamcinolone
In this study bupivacaine is chosen as the local anesthetic as it inhibits prostaglandin production by binding to the E2 receptor providing an anti-inflammatory effect It is a lipophilic amide-type anesthetic with 100 bioavailability and a longer duration than other local anesthetics Additionally it produces a more significant blockade of sensory and sympathetic nerve fibers than motor fibers differentiating it from other local anesthetics
Recent guidelines for the treatment of knee osteoarthritis highlight the recommendation of intra-articular corticosteroid injections However several studies mention that systemic and local corticosteroid effects can cause adverse effects such as skin atrophy hypertension insulin resistance decreased bone mineralization and septic arthritis among others Nonetheless these effects have not demonstrated a direct relationship with pain functionality or radiological changes
The clinical benefit of corticosteroid administration compared to local anesthesia alone remains unclear Given the potential adverse effects corticosteroids may not be suitable as adjuvants Therefore genicular nerve block using local anesthetic alone proves to be a promising technique avoiding the use of corticosteroids and not being an intra-articular procedure
A study is proposed at a tertiary hospital in the Community of Madrid Hospital Universitario Fundación Alcorcón Considering the absence of previous studies that evaluate and quantify the three described treatment options this study aims to address this objective through a pilot experimental randomized controlled trial All patients will receive guidelines for an exercise program and the outcomes of adding genicular nerve block with and without corticosteroid will be assessed This unprecedented study could identify the optimal treatment for this prevalent and debilitating condition in a significant portion of the population Additionally it will help optimize resource allocation for these patients by identifying the best therapeutic target thus avoiding unnecessary resource consumption
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None