Knee Arthroscopy, Acute Pain
Conditions
Keywords
Knee Arthroscopy, Acute Pain, 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 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%).
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.
Interventions
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.
DRUGRopivacaine 0.2% 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 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
Sponsors
Paola M Zamora Munoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 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. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ropivacaine 0.75% 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 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: 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. | 36 |
| Ropivacaine 0.2% 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 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: 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. | 34 |
| Total | 70 |
Baseline characteristics
| Characteristic | Ropivacaine 0.75% Injectable Solution | Ropivacaine 0.2% Injectable Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 34 Participants | 70 Participants |
| Age, Continuous | 40 years STANDARD_DEVIATION 12 | 38 years STANDARD_DEVIATION 11 | 39 years STANDARD_DEVIATION 11 |
| Body Mass Index <25 kg/m² | 18 Participants | 17 Participants | 35 Participants |
| Body Mass Index OVERWEIGHT (25 kg/m² or more) | 18 Participants | 17 Participants | 35 Participants |
| Etiology of surgery Degenerative | 10 Participants | 5 Participants | 15 Participants |
| Etiology of surgery Trauma | 26 Participants | 29 Participants | 55 Participants |
| Outerbridge Clasification II (Fissures less than 50% of the cartilage thickness, 1 mm or less in depth) | 15 Participants | 19 Participants | 34 Participants |
| Outerbridge Clasification III (Fissures extending more than 50% of the cartilage thickness but without full loss, 1-2 mm) | 5 Participants | 8 Participants | 13 Participants |
| Outerbridge Clasification I (Softening or swelling of the cartilage, without visible fissures or fragmentation). | 16 Participants | 7 Participants | 23 Participants |
| Physical Activity Active | 7 Participants | 12 Participants | 19 Participants |
| Physical Activity Sedentary | 29 Participants | 22 Participants | 51 Participants |
| Race/Ethnicity, Customized Latin American | 36 Participants | 34 Participants | 70 Participants |
| Region of Enrollment Mexico | 36 participants | 34 participants | 70 participants |
| Sex: Female, Male Female | 25 Participants | 26 Participants | 51 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
| Time of articular cartilage lesion evolution <14 days | 31 Participants | 28 Participants | 59 Participants |
| Time of articular cartilage lesion evolution >14 days | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 34 |
| other Total, other adverse events | 0 / 36 | 0 / 34 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 |
Outcome results
Primary
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.
Time frame: 2 hours postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ropivacaine 0.75% Injectable Solution | Number of Participants With Acute Pain (Visual Analogue Scale) | 10 Participants |
| Ropivacaine 0.2% Injectable Solution | Number of Participants With Acute Pain (Visual Analogue Scale) | 29 Participants |
Secondary
Number of Participants With Opioid Administration
The administration of opioids in the first two hours of postoperative for necessary reasons (pain ≥4 points) is recorded by the physician in charge.
Time frame: 2 hours postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ropivacaine 0.75% Injectable Solution | Number of Participants With Opioid Administration | 7 Participants |
| Ropivacaine 0.2% Injectable Solution | Number of Participants With Opioid Administration | 12 Participants |