ropivacaine: "Comparison of Intra-articular of 2% Ropivacaine vs. 7.5% Ropivacaine in Postoperative of Knee Arthroscopy"

Sponsor

Paola M Zamora Munoz (Other)

Overall Status

Completed

CT.gov ID

NCT05807945

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 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%).

Condition or Disease	Intervention/Treatment	Phase
Knee Arthroscopy Acute Pain	Drug: Ropivacaine 7.5% Injectable Solution Drug: Ropivacaine 2% Injectable Solution	Phase 4

Detailed Description

In previous studies the prevalence of moderate-severe intensity pain in patients post knee arthroscopy is 71.2%, and the prevalence of acute pain in post-operative is 37.5%, 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Comparison of the Effect of Intra-articular Administration of 2% Ropivacaine vs. 7.5% Ropivacaine as an Analgesic in the Immediate Postoperative Period of Knee Arthroscopy in Acute Injuries at the ABC Medical Center

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Feb 1, 2023

Actual Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ropivacaine 7.5% 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 7.5%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.	Drug: Ropivacaine 7.5% 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 7.5%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Active Comparator: Ropivacaine 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 2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.	Drug: Ropivacaine 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 2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.

Arm

Intervention/Treatment

Experimental: Ropivacaine 7.5% 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 7.5%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.

Drug: Ropivacaine 7.5% Injectable Solution

Active Comparator: Ropivacaine 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 2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.

Drug: Ropivacaine 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 2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.

Outcome Measures

Primary Outcome Measures

Presence of Acute Pain (Visual analogue scale) [2 hours postoperative]
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.

Secondary Outcome Measures

Frequency of Opioid administration [2 hours postoperative]
The administration of opioids in the first two hours of postoperative for necessary reasons (pain ≥4 points) is recorded by the physician in charge.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American British Cowdray Medical Center	Mexico City	Cuajimalpa	Mexico	05300

Sponsors and Collaborators

Paola M Zamora Munoz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Paola M Zamora Munoz, Principal Investigator, American British Cowdray Medical Center

ClinicalTrials.gov Identifier:

NCT05807945

Other Study ID Numbers:

001230620

First Posted:

Apr 11, 2023

Last Update Posted:

Apr 11, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Paola M Zamora Munoz, Principal Investigator, American British Cowdray Medical Center

Knee Arthroscopy

Acute Pain

Ropivacaine

Additional relevant MeSH terms:

Acute Pain

Ropivacaine

Pharmaceutical Solutions

Study Results

No Results Posted as of Apr 11, 2023