"Comparison of Intra-articular of 2% Ropivacaine vs. 7.5% Ropivacaine in Postoperative of Knee Arthroscopy"
Status:
Completed
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
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 7.5% and 2.0% 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 37.5% in
patients with ropivacaine at 2% and frequency of 7.5% in patients with ropivacaine at 7.5%).