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This study will evaluate the ability of trigger point injections completed immediately following a total knee arthroplasty decrease pain scores and opioid use compared to sham injections. Given the current state of opioid dependency in the United States there needs to be a more focused attempt at treating post-operative pain without use of opioids. Given the manipulation of soft tissue during a total knee arthroplasty there seems to be a high correlation with pain and myofascial pain syndrome. This study will include an experimental (trigger point injection) and control (sham injection) group who are all undergoing a total knee arthroplasty. This is a pilot study that will include a maximum of 100 total patients (although it is planned for the study to be much smaller with a planned 10-15 patients per group). The procedure that will be completed is a trigger point injection with use of 1% lidocaine without epinephrine along the distal aspect of the vastus medialis and lateralis, proximal aspect of the medial and lateral gastrocnemius muscle bellies. The sham injection will be completed by pressing the needle against the skin without injecting any fluid. There will be a "blind" between the patient and the needle with both arms of the study. These patients will be followed up on POD1, and during weeks 2 and 6 follow-up where they will be given questionnaires to assess pain (visual analogue scale) and opioid use, and asked to bring their opioid medications to the clinic to assess the morphine milligrams equivalent (MME).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group - participants receiving trigger point injections | Experimental | The participant will receive trigger point injections with 1% lidocaine without epinephrine in two muscles in the thigh and two muscles in the calf immediately after having knee replacement surgery. |
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| Sham comparator - Participants not receiving trigger point injections | Sham Comparator | The patient will not receive an injection, but instead a façade of an injection by having the same physical set-up to prepare for an injection (the same as for the experimental group), but there will be a barrier between the patient's view and the syringe so that he/she will not know an injection was not given. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigger point injection (lidocaine) | Drug | A trigger point injection utilizing lidocaine 1% without epinephrine will be injected into several muscles bellies immediately following surgery to halt a trigger point from forming. One group will receive this type of intervention and the sham group will not receive any type of injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores on the Visual Analog Scale | 1. Change in Visual Analog Scale (VAS) pain scores The VAS is a numbered scale assessing pain severity using a number which describes the average level of pain since being discharged. Participants are to put a hash mark "/" on a numbered scale ranging from 0-100. Zero (0) is no pain and 100 is severe intolerable pain | From enrollment to the end of treatment at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | 1. Compare the total opioid use between study groups (experimental, sham comparator). Opioid use will be measured during their inpatient stay using the Medication Administration Record (MAR) Summary in the electronic medical record; and completing an Opioid Use questionnaire and counting the number of pills remaining during post-operative/follow-up study visits. Inpatient opioid use will be calculated by using the morphine dosage and number of doses per day. Outpatient opioid use will be obtained by reviewing responses to the Opioid Use questionnaire and counting the number of pills remaining from the prescription given at the time of discharge. Participants will be asked to bring their medication (opioids) to their post-operative/follow-up study visits. This method will allow the investigator to measure total opioid use (injectable and pill) during their inpatient and outpatient course. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dustin L Bennett | David Grant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Grant Medical Center | Fairfield | California | 94535 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group - Participants Receiving Trigger Point Injections | The participant will receive trigger point injections with 1% lidocaine without epinephrine in two muscles in the thigh and two muscles in the calf immediately after having knee replacement surgery. |
| FG001 | Sham Comparator - Participants Not Receiving Trigger Point Injections | The patient will not receive an injection, but instead a façade of an injection by having the same physical set-up to prepare for an injection (the same as for the experimental group), but there will be a barrier between the patient's view and the syringe so that he/she will not know an injection was not given. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group - Participants Receiving Trigger Point Injections | The participant will receive trigger point injections with 1% lidocaine without epinephrine in two muscles in the thigh and two muscles in the calf immediately after having knee replacement surgery. |
| BG001 | Sham Comparator - Participants Not Receiving Trigger Point Injections |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Due to the total knee replacements not being conducted on 18 year olds or younger this demographic was not considered in our research |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Scores on the Visual Analog Scale | 1. Change in Visual Analog Scale (VAS) pain scores The VAS is a numbered scale assessing pain severity using a number which describes the average level of pain since being discharged. Participants are to put a hash mark "/" on a numbered scale ranging from 0-100. Zero (0) is no pain and 100 is severe intolerable pain | Limited timeline for follow-up restricted total number of participants for the last follow-up interval (6 week) | Posted | Mean | Standard Deviation | Pain Scores on the Visual Analog Scale | From enrollment to the end of treatment at 6 weeks |
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from enrollment until the 6 week post-operative follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group - Participants Receiving Trigger Point Injections | The participant will receive trigger point injections with 1% lidocaine without epinephrine in two muscles in the thigh and two muscles in the calf immediately after having knee replacement surgery. |
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Convenience sampling, Hawthorne effect, Sample Size, Peri-articular musculature targeted, Generalizability
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dustin Bennett | U.S. Air Force | 707-423-3568 | dustin.l.bennett4.mil@health.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2025 | Jan 21, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2025 | Oct 2, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Sham Comparator | Other | This arm of the study will not receive any injection. |
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| From enrollment to the end of treatment at 6 weeks |
The patient will not receive an injection, but instead a façade of an injection by having the same physical set-up to prepare for an injection (the same as for the experimental group), but there will be a barrier between the patient's view and the syringe so that he/she will not know an injection was not given. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Number of Participants who are Military Retired or Military Dependents | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| OG001 | Sham Comparator - Participants Not Receiving Trigger Point Injections | The patient will not receive an injection, but instead a façade of an injection by having the same physical set-up to prepare for an injection (the same as for the experimental group), but there will be a barrier between the patient's view and the syringe so that he/she will not know an injection was not given. |
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| Secondary | Opioid Use | 1. Compare the total opioid use between study groups (experimental, sham comparator). Opioid use will be measured during their inpatient stay using the Medication Administration Record (MAR) Summary in the electronic medical record; and completing an Opioid Use questionnaire and counting the number of pills remaining during post-operative/follow-up study visits. Inpatient opioid use will be calculated by using the morphine dosage and number of doses per day. Outpatient opioid use will be obtained by reviewing responses to the Opioid Use questionnaire and counting the number of pills remaining from the prescription given at the time of discharge. Participants will be asked to bring their medication (opioids) to their post-operative/follow-up study visits. This method will allow the investigator to measure total opioid use (injectable and pill) during their inpatient and outpatient course. | Due to time constraints our study was only able to evaluate 3 participants in each arm of the study on the 6 week post-operative appointment. | Posted | Mean | Standard Deviation | MME | From enrollment to the end of treatment at 6 weeks |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Sham Comparator - Participants Not Receiving Trigger Point Injections | The patient will not receive an injection, but instead a façade of an injection by having the same physical set-up to prepare for an injection (the same as for the experimental group), but there will be a barrier between the patient's view and the syringe so that he/she will not know an injection was not given. | 0 | 5 | 0 | 5 | 0 | 5 |
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| Aniline Compounds |
| D000588 | Amines |
| week 2 |
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| week 6 |
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