Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| STU00088239 | Other Identifier | Northwestern University IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.
The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Active Comparator | Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine |
|
| Control Group | Placebo Comparator | Ultrasound-guided sham block with 10 ml of preservative free normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 10 ml of 0.25% bupivacaine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption (mg morEq) | Opioid consumption (morphine equivalents) | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Pain Score | Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery. | Pain burden at 36hr |
| Length of Hospitalization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antoun Nader, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Group | Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine Bupivacaine: 10 ml of 0.25% bupivacaine |
| FG001 | Control Group | Ultrasound-guided sham block with 10 ml of preservative free normal saline Preservative free normal saline: 10 ml of preservative free normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Group | Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine Bupivacaine: 10 ml of 0.25% bupivacaine |
| BG001 | Control Group | Ultrasound-guided sham block with 10 ml of preservative free normal saline Preservative free normal saline: 10 ml of preservative free normal saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Opioid Consumption (mg morEq) | Opioid consumption (morphine equivalents) | Posted | Median | Inter-Quartile Range | Morphine Equivalents | 36 hours |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Group | Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine Bupivacaine: 10 ml of 0.25% bupivacaine |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antoun Nader | Northwestern University, Feinberg School of Medicine | 312-695-3045 | a-nader2@northwestern.edu |
Not provided
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Preservative free normal saline | Drug | 10 ml of preservative free normal saline |
|
|
The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.
| 0 to 192 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Visual Analog Scale Pain Score | Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery. | Posted | Median | Inter-Quartile Range | scores*hours | Pain burden at 36hr |
|
|
|
| Secondary | Length of Hospitalization | The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met. | Posted | Mean | 95% Confidence Interval | hours | 0 to 192 hours |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control Group | Ultrasound-guided sham block with 10 ml of preservative free normal saline Preservative free normal saline: 10 ml of preservative free normal saline | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |