"Comparison of Intra-articular of 0.2% Ropivacaine vs. 0.75% Ropivacaine in Postoperative of Knee Arthroscopy"

NCT05807945 | Completed Phase 4 Results DMC

• 1 other identifier: 001230620
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 0.75% and 0.2% 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 0.2% and frequency of 0.75% in patients with ropivacaine at 0.75%).

Conditions

Knee Arthroscopy; Acute Pain

Keywords

Knee Arthroscopy; Acute Pain; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute Pain (Visual Analogue Scale)

  The result is quantified continuously in a scale from 0 (No pain) to 10 (Worst pain imaginable) points. Acute pain is labeled of a value ≥4 points.

  2 hours postoperative

Secondary Outcomes (1)

• Number of Participants With Opioid Administration

  2 hours postoperative

Study Arms (2)

Ropivacaine 0.75% Injectable Solution

EXPERIMENTAL

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.

Drug: Ropivacaine 0.75% Injectable Solution

Ropivacaine 0.2% Injectable Solution

ACTIVE COMPARATOR

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.

Drug: Ropivacaine 0.2% Injectable Solution

Interventions

Ropivacaine 0.75% Injectable Solution DRUG

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

Ropivacaine 0.2% Injectable Solution DRUG

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Paola M Zamora Munoz: lead

Study Sites (1)

American British Cowdray Medical Center

Mexico City, Cuajimalpa, 05300, Mexico

Location

Related Publications (33)

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MeSH Terms

Conditions

Acute Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The main limitation of our study consists in the fact that the evaluation of pain is not an objective variable;, it was not possible for us to evaluate pain over a longer period of follow-up, due to the out-patient nature of the surgery.Our study did not evaluate the pre-operative intensity of pain, which is a weakness; however, patients were classified according to the severity of articular cartilage injury, variable that correlates with pain intensity.

Results Point of Contact

• Title: Angel Cruz Miranda
• Organization: ABC Medical Center

cruz.angel@aol.com

5516647121

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking was performed once the patient agreed to participate; the physician in charge of randomization informs the anesthesiologist of the maneuver that corresponds to the patient programmed for surgery, who prepares the dose for the patient and hands it to the physician who applies the maneuver (who is blinded to the maneuver). All patients receive 10 ml of solution with different doses of ropivacaine, the application vehicles being equal in physical appearance. The physician who evaluate the outcome does not participate in the randomization, surgery or application of the maneuver, and remains blinded to the dose the patient receives, as does the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After confirming that the patients meet the selection criteria, they are invited to participate in the study. Upon accepting through signed informed consent, the physician in charge of randomization (physician 1) is informed and the surgery scheduled. The day of the surgery, the physician in charge of randomization reports the maneuver to be received from the anesthesiologist (physician 2) in charge, who prepares the dose of ropivacaine and gives it to a physician blinded to the maneuver (physician 3); this physician applies the ropivacaine intraarticular to the patient. The level of pain is evaluated two hours after the end of surgery by a physician blinded to the maneuver the patient has received (physician 4), while the patient is in his room, and the presence of acute-moderate-severe pain (4-10 points) is evaluated by a visual analog scale (vas) while the patient is requested to flex and extend the knee.

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: April 11, 2023
• Study Start: April 1, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)