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This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adductor Canal Block (ACB) Only | Active Comparator | Participants randomized to the ACB only group will receive an adductor canal block alone. |
|
| ACB + iPACK | Active Comparator | Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adductor Canal Block (ACB) Only | Drug | Patients will receive an ACB with lidocaine skin wheal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | The primary endpoint will measure subjective pain scores using a Visual Analog Scale ranging from 0 (no pain) to 100 (severe intolerable pain) at 12-hour intervals during the first 72 hours of the postoperative window. A higher score means worse outcome. | 0-72 hours post op |
| Measure | Description | Time Frame |
|---|---|---|
| Total Postoperative Opioid Consumption (Total MME) | The secondary endpoints will measure perioperative opioid consumption through postoperative day 2 in 12-hour intervals and converted into morphine milligram equivalents using standard conversions. | up to 72 hours post-op |
| Range of Motion (Degrees) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carey Breabaker, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
Each participant contributed one study knee. They underwent an ACL reconstruction on one single knee to qualify for participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adductor Canal Block (ACB) Only | Participants randomized to the ACB only group will receive an adductor canal block alone. Adductor Canal Block (ACB) Only: Patients will receive an ACB with lidocaine skin wheal |
| FG001 | ACB + iPACK | Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block. Adductor Canal Block (ACB) + iPACK Block: Patients will receive an ACB with iPACK block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adductor Canal Block (ACB) Only | Participants randomized to the ACB only group will receive an adductor canal block alone. Adductor Canal Block (ACB) Only: Patients will receive an ACB with lidocaine skin wheal |
| BG001 | ACB + iPACK |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The primary endpoint will measure subjective pain scores using a Visual Analog Scale ranging from 0 (no pain) to 100 (severe intolerable pain) at 12-hour intervals during the first 72 hours of the postoperative window. A higher score means worse outcome. | Posted | Mean | Standard Error | units on a scale | 0-72 hours post op |
|
Adverse events were collected from the time randomization occurred through the end of post-op Day 3, an average of 4 days.
Patients self reported if they developed any type of nerve-block related adverse event such as nerve damage, local anesthetic systemic toxicity (LAST), numbness, or infection at injection site, etc. Additionally, they also self-reported if they had any surgical adverse events such as incision infection. All patient-reported adverse events were followed up on to confirm reported details.
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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 | Adductor Canal Block (ACB) Only | Participants randomized to the ACB only group will receive an adductor canal block alone. Adductor Canal Block (ACB) Only: Patients will receive an ACB with lidocaine skin wheal |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nerve Block Adverse Event | Injury, poisoning and procedural complications | Non-systematic Assessment | Any event reported to be cause by the nerve block. This can include nerve damage, numbness and tingling, infection at injection site, etc. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carey Brewbaker | Medical University of South Carolina | 843-792-2322 | brewbake@musc.edu |
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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 | Jun 17, 2022 | Apr 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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Only the patient will be blinded to the treatment group.
| Adductor Canal Block (ACB) + iPACK Block | Drug | Patients will receive an ACB with iPACK block |
|
An additional secondary endpoint is the range of motion, measured in degrees, of the operative knee at post-op visit 1 and 2. The post-op measurements will be compared to the pre-operative measurements. The scale of range of motion is from 0 - 135 degrees. The higher the score (degrees), the better the outcome. |
| up to two months after surgery |
Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
Adductor Canal Block (ACB) + iPACK Block: Patients will receive an ACB with iPACK block
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Preoperative VAS Pain Score | Median | Inter-Quartile Range | units on a scale |
|
| ACL Side | Left ACLs vs. Right ACLs repaired | Number | participants |
|
|
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| Secondary | Total Postoperative Opioid Consumption (Total MME) | The secondary endpoints will measure perioperative opioid consumption through postoperative day 2 in 12-hour intervals and converted into morphine milligram equivalents using standard conversions. | Posted | Mean | Standard Error | morphine milligram equivalents | up to 72 hours post-op |
|
|
|
| Secondary | Range of Motion (Degrees) | An additional secondary endpoint is the range of motion, measured in degrees, of the operative knee at post-op visit 1 and 2. The post-op measurements will be compared to the pre-operative measurements. The scale of range of motion is from 0 - 135 degrees. The higher the score (degrees), the better the outcome. | Posted | Mean | Standard Error | degrees | up to two months after surgery |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 6 |
| 34 |
| EG001 | ACB + iPACK | Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block. Adductor Canal Block (ACB) + iPACK Block: Patients will receive an ACB with iPACK block | 0 | 38 | 0 | 38 | 8 | 38 |
|
| Surgical Adverse Event | Surgical and medical procedures | Non-systematic Assessment | Adverse event related to the ACL repair. This can include infection at surgical incision site, etc. |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012959 |
| Socioeconomic Factors |
| 36 hours post-op |
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| 48 hours post-op |
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| 60 hours post-op |
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| 72 hours post-op |
|