Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807945
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2023-03-05
Brief Title:
Comparison of Intra-articular of 02 Ropivacaine vs 075 Ropivacaine in Postoperative of Knee Arthroscopy
Sponsor:
Paola M Zamora Munoz
Organization:
American British Cowdray Medical Center
Study Overview
Official Title:
Comparison of the Effect of Intra-articular Administration of 02 Ropivacaine vs 075 Ropivacaine as an Analgesic in the Immediate Postoperative Period of Knee Arthroscopy in Acute Injuries at the ABC Medical Center
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ropivacaine
Brief Summary:
All patients with acute lesions that attend the orthopedic and trauma center of the ABC medical center are invited to participate in the study Those that meet the inclusion criteria and later sign an informed consent are randomized to receive 10 ml of a solution with ropivacaine at 075 and 02 intraarticular for the first 5 minutes after the end of surgery closing of surgical wounds Both the patient the physician who applies it and the evaluator of outcomes remain blinded to the dose of ropivacaine the patient receives
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 375 in patients with ropivacaine at 02 and frequency of 075 in patients with ropivacaine at 075
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 375 in patients with ropivacaine at 02 and frequency of 075 in patients with ropivacaine at 075
Detailed Description:
In previous studies the prevalence of moderate-severe intensity pain in patients post knee arthroscopy is 712 and the prevalence of acute pain in post-operative is 375 surpassing the prevalence when compared with other surgical procedures of various specialties
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None