"Comparison of Intra-articular of 0.2% Ropivacaine vs. 0.75% Ropivacaine in Postoperative of Knee Arthroscopy"
NCT ID: NCT05807945
Last Updated: 2024-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2020-04-01
2023-02-01
Brief Summary
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Two hours after the end of the surgery, while the patient is in his room, the presence of pain is evaluated by a visual analog scale (VAS), while the patient is asked to flex and extend his knee. The result is quantified continuously, to later categorize the pain in none to slight pain (0-3 points) and moderate-severe pain (4-10 points). All the information is recorded on established forms in the clinical file (general data), that includes the variables of interest for the study, and is reported by the physicians after standardization of all those in charge with collecting information to comply with the conceptual and operative operationalization of the variables described in the research protocol. In addition to the evaluation of pain, the administration of opioids to patients for necessary reasons (presence of pain) by the physicians in charge is recorded.
It is hoped that, in patients with knee arthroscopy for acute lesion, there is a difference in the frequency of moderate-severe pain of 30% in the post-operative (frequency of 37.5% in patients with ropivacaine at 0.2% and frequency of 0.75% in patients with ropivacaine at 0.75%).
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Detailed Description
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The administration of opioids is part of common practice in managing pain. However, it represents a risk for patients due to adverse effects and the high risk of dependence. It is necessary to seek alternatives that reduce the consumption of opioids in patients post knee arthroscopy.
Characteristics of the patients reported in other studies, such as sex, body mass index, sedentarism, the cause, duration and use of tourniquet in surgery, in addition to the type of lesion of articular cartilage and the presence of neuropathies, may influence in the presence of pain severity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ropivacaine 0.75% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.75% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.2% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.2% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Interventions
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Ropivacaine 0.75% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Ropivacaine 0.2% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Eligibility Criteria
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Inclusion Criteria
* Articular cartilage lesion Grade I, II or III by Outerbridge
* Elective knee surgery
* Patients with any of the following diagnoses:
* Simple meniscal lesion
* Lesion of a single knee (unilateral)
Exclusion Criteria
* History of knee surgery (orthopedic)
* Instability that includes knee ligament lesions
* Addictions
* Mental diseases in medical treatment
* Hepatic diseases
* Allergy to any of the medications used in the study
* Epidural or peridural anesthesia
* Chronic pain in treatment
* Postoperative drain of knee arthroscopy
* Pregnant or lactating
18 Years
50 Years
ALL
Yes
Sponsors
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Paola M Zamora Munoz
OTHER
Responsible Party
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Paola M Zamora Munoz
Principal Investigator
Locations
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American British Cowdray Medical Center
Mexico City, Cuajimalpa, Mexico
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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001230620
Identifier Type: -
Identifier Source: org_study_id
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