"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: 0
• Participant gender: All

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%).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Paola M Zamora Munoz
• Treatments: Pharmaceutical Solutions; Ropivacaine

Criteria

Inclusion Criteria:

• Mental health: healthy (not taking any medication)

• 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:

• Neuromotor diseases (alterations in step, strength or sensitivity)

• 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