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The purpose of this study is to learn if using an Interspace between the Popliteal Artery and Capsule of the Knee (iPACK) injection technique (also called a "nerve block") that numbs the nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK technique uses a numbing solution (local anesthetics) that is injected behind the knee to reduce pain and to help straighten the knee. This block may affect movement in the leg and make the legs weak, but thing is rare. A few institutions use the iPACK block for patients having total knee replacements, with the hope of providing good pain relief combined with improved mobility after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iPACK Block Group | Experimental | A nerve block technique using a numbing medication called ropivacaine. |
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| Sham Group | Placebo Comparator | The same nerve block technique as above, however using an inactive solution of salt water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Local anesthetic (numbing drug) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Able to Hyperextend the Knee After Surgery | Ability to hyperextend the knee after surgery | Within 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulation as Measured by Distance Walked After Surgery | Post-operative Day 0 | |
| Pain as Measure by Numerical Rating Scale (NRS) 11 | The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable"). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27713 | United States |
Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
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| ID | Title | Description |
|---|---|---|
| FG000 | iPACK Block Group | A nerve block technique using a numbing medication called ropivacaine. Ropivacaine: Local anesthetic (numbing drug) Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 6, 2021 |
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| Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block | Procedure | An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee. |
|
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| Saline | Drug | An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. |
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| 24 hours |
| Cumulative Opioid Consumption | Total amount of opioids used | 24 hours |
| FG001 |
| Sham Group |
The same nerve block technique as above, however using an inactive solution of salt water. Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee. Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | iPACK Block Group | A nerve block technique using a numbing medication called ropivacaine. Ropivacaine: Local anesthetic (numbing drug) Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee. |
| BG001 | Sham Group | The same nerve block technique as above, however using an inactive solution of salt water. Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee. Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Number of Participants Able to Hyperextend the Knee After Surgery | Ability to hyperextend the knee after surgery | Posted | Count of Participants | Participants | Within 8 hours |
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| Secondary | Ambulation as Measured by Distance Walked After Surgery | Posted | Mean | Standard Deviation | feet | Post-operative Day 0 |
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| Secondary | Pain as Measure by Numerical Rating Scale (NRS) 11 | The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable"). | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
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| ||||||||||||||||||||||||||||||
| Secondary | Cumulative Opioid Consumption | Total amount of opioids used | Posted | Mean | Standard Deviation | IV morphine equivalents | 24 hours |
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From enrollment in study until 24 hours post-op.
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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 | iPACK Block Group | A nerve block technique using a numbing medication called ropivacaine. Ropivacaine: Local anesthetic (numbing drug) Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Sham Group | The same nerve block technique as above, however using an inactive solution of salt water. Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee. Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. | 0 | 25 | 0 | 25 | 0 | 25 |
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Technical problems with allocations leading to unrelabile and uninterpretable data.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| W. Michael Bullock, MD, PhD | Duke University Medical Center | 919-681-6437 | william.bullock@duke.edu |
| Nov 22, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 6, 2021 | Nov 19, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D003766 | Dental Occlusion |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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