A Phase 4 interventional study of Ropivacaine and Normal saline in Osteoarthritis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-21.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
Corticosteroid injections are commonly used for the symptomatic treatment of knee osteoarthritis. Common practice is to inject the joint with a combination of corticosteroid and local anesthetic, with the rationale of providing longer duration pain relief with the corticosteroid and immediate, though short duration relief with the anesthetic. However, multiple in vitro and animal studies have shown that local anesthetic may be harmful to chondrocytes. Despite this data, use of intra-articular anesthetic remains widespread. Many clinicians believe incorporating the anesthetic is important because it can provide immediate pain relief and facilitate patient confidence in the treatment program. However, there is no published data to validate this reasoning. Therefore, the anesthetic has unknown clinical benefit and may have adverse effects on articular cartilage. In light of this, the investigators question the routine use of anesthetics in joint injections. The purpose of this study is to compare the effects of knee joint injections using: 1) corticosteroid with local anesthetic versus 2) corticosteroid with normal saline.
4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 29 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion criteria:
0.2% ropivacaine and methylprednisolone knee joint injection
Drug: Ropivacaine · Drug: Methylprednisolone
0.9% normal saline and methylprednisolone knee joint injection
Drug: Normal saline · Drug: Methylprednisolone
4cc 0.5% ropivacaine
Also known as: Naropin
4cc of sterile normal saline (0.9%)
Also known as: Sodium Chloride
1cc 40mg methylprednisolone
Also known as: Depo-Medrol
The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale
The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: 3 months after the injection
Pain Scale Score
Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months.
Time frame: Pre-injection, immediately post-injection, 2 weeks, 3 months
Tegner Activity Level Scale
The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score \>6 can only be achieved if the person participates in recreational or competitive sport.
Time frame: baseline (pre-injection), 2 weeks, 3 months
| Milestone | Ropivacaine and Methylprednisolone | Saline and Methylprednisolone |
|---|---|---|
| Started | 15 | 14 |
| Completed | 15 | 14 |
| Not completed | 0 | 0 |
The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
| units on a scale | Ropivacaine and Methylprednisolone | Saline and Methylprednisolone |
|---|---|---|
| The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale | 63.1 ± 16.1 | 67.2 ± 14.4 |
Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months.
| units on a scale | Ropivacaine and Methylprednisolone | Saline and Methylprednisolone |
|---|---|---|
| Pre-injection Activity | 6.4 ± 2 | 5.8 ± 2.5 |
| Pre-injection Rest | 2.4 ± 2 | 4 ± 2 |
| Immediately Post-injection Activity | 1.9 ± 2.3 | 2.4 ± 2.2 |
| Immediately Post-injection Rest | 1.2 ± 1.5 | 1.4 ± 1.7 |
| 2 Weeks Activity | 3.6 ± 2.5 | 3.6 ± 2 |
| 2 Weeks Rest | 1.7 ± 2 | 2.7 ± 2.2 |
| 3 Months Activity | 3.9 ± 2.7 | 4.6 ± 2.4 |
| 3 Months Rest | 2.6 ± 2.2 | 2.8 ± 2.4 |
The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score \>6 can only be achieved if the person participates in recreational or competitive sport.
| units on a scale | Ropivacaine and Methylprednisolone | Saline and Methylprednisolone |
|---|---|---|
| baseline (pre-injection) | 3.5 ± 2.2 | 3.0 ± 1.6 |
| 2 weeks | 4.3 ± 1.7 | 3.2 ± 1.3 |
| 3 months | 3.5 ± 2.1 | 3 ± 1.7 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ropivacaine and Methylprednisolone | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Saline and Methylprednisolone | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Ropivacaine and Methylprednisolone | Saline and Methylprednisolone | Total |
|---|---|---|---|
| Mean | 57 ± 7.43 | 57 ± 11.8 | 57 ± 9.58 |
| Sex: Female, Male(Participants) | Ropivacaine and Methylprednisolone | Saline and Methylprednisolone | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 7 | 6 | 13 |
| Region of Enrollment(Participants) | Ropivacaine and Methylprednisolone | Saline and Methylprednisolone | Total |
|---|---|---|---|
| United States | 15 | 14 | 29 |
| Body Mass Index (BMI)(kg/m^2) | Ropivacaine and Methylprednisolone | Saline and Methylprednisolone | Total |
|---|---|---|---|
| Mean | 29.9 ± 7.68 | 30.9 ± 6.46 | 30.4 ± 7.01 |
| Knee Effusion(Participants) | Ropivacaine and Methylprednisolone | Saline and Methylprednisolone | Total |
|---|---|---|---|
| Yes | 5 | 4 | 9 |
| No | 10 | 10 | 20 |
Plan to share: No
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