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An observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty.
Subjects undergoing total knee arthroplasty will receive a preoperative adductor canal block with continuous catheter. Following a standardized general anesthetic for the procedure, subjects will be asked to rate their pain using the NRS-11 pain scale in the recovery room. Once the pain is reported at a 5/10 or above, a femoral nerve block will be performed using either 2% chloroprocaine or saline placebo (randomized). Pain scores are then evaluated over the next 30 minutes by a blinded investigator to determine if the femoral block adds any additional analgesic benefit over an adductor canal block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chloroprocaine | Active Comparator | 15 ml of 2% chloroprocaine via a femoral nerve block technique |
|
| saline | Sham Comparator | 15 ml of 0.9% saline via a femoral nerve block technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active comparator: chloroprocaine | Procedure | 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable). | Baseline, up to 30 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Gadsden, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chloroprocaine | 15 ml of 2% chloroprocaine via a femoral nerve block technique Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. |
| FG001 | Saline | 15 ml of 0.9% saline via a femoral nerve block technique Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chloroprocaine | 15 ml of 2% chloroprocaine via a femoral nerve block technique Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. |
| BG001 | Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. | Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable). | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, up to 30 minutes. |
|
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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 | Chloroprocaine | 15 ml of 2% chloroprocaine via a femoral nerve block technique Active comparator: chloroprocaine: 15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Gadsden | Duke University Medical Center | 919-681-6437 | jeff.gadsden@duke.edu |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C004616 | chloroprocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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randomized, blinded observational study
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Group allocation by sealed envelope; unblinded investigator prepared syringes of study drug (chloroprocaine vs. saline), which look identical to blinded investigator and assessor.
|
| Sham comparator: saline | Procedure | 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. |
|
|
15 ml of 0.9% saline via a femoral nerve block technique Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Saline | 15 ml of 0.9% saline via a femoral nerve block technique Sham comparator: saline: 15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |