ACL Injury, Post Operative Pain
Conditions
Keywords
acl injury, acl repair
Brief summary
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.
Interventions
Patients will receive an ACB with lidocaine skin wheal
Patients will receive an ACB with iPACK block
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only the patient will be blinded to the treatment group.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 12 years and older * Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.
Exclusion criteria
* Any contraindication to receiving regional anesthesia. This may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury. * Patients undergoing hamstring graft or allograft for ACL * Pre-existing infection at the site of injury * Patients on chronic opioid treatments * Pre-existing sensory or motor deficit in operative extremity * Patients having a revision of previous ACL reconstruction * Pregnant and/or lactating women * Weighs less than 40kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | 0-72 hours post op | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Postoperative Opioid Consumption (Total MME) | up to 72 hours post-op | 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. |
| Range of Motion (Degrees) | up to two months after surgery | 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. |
Countries
United States
Participant flow
Pre-assignment details
Each participant contributed one study knee. They underwent an ACL reconstruction on one single knee to qualify for participation in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| 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 | 38 |
| Total | 72 |
Baseline characteristics
| Characteristic | Total | ACB + iPACK | Adductor Canal Block (ACB) Only |
|---|---|---|---|
| ACL Side Left ACL | 33 participants | 16 participants | 17 participants |
| ACL Side Right ACL | 39 participants | 22 participants | 17 participants |
| Age, Continuous | 22.7 years STANDARD_DEVIATION 8.62 | 22.8 years STANDARD_DEVIATION 8.53 | 22.6 years STANDARD_DEVIATION 8.74 |
| Body Mass Index | 25.7 kg/m^2 STANDARD_DEVIATION 4.63 | 25.9 kg/m^2 STANDARD_DEVIATION 5.46 | 25.4 kg/m^2 STANDARD_DEVIATION 3.49 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 37 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Preoperative VAS Pain Score | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Race/Ethnicity, Customized Black | 18 Participants | 9 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 51 Participants | 27 Participants | 24 Participants |
| Sex: Female, Male Female | 36 Participants | 20 Participants | 16 Participants |
| Sex: Female, Male Male | 36 Participants | 18 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 38 |
| other Total, other adverse events | 6 / 34 | 8 / 38 |
| serious Total, serious adverse events | 0 / 34 | 0 / 38 |
Outcome results
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.
Time frame: 0-72 hours post op
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adductor Canal Block (ACB) Only | Pain Scores | 60 hours post-op | 41.1 units on a scale | Standard Error 4.39 |
| Adductor Canal Block (ACB) Only | Pain Scores | Pain at Discharge | 41.5 units on a scale | Standard Error 27.3 |
| Adductor Canal Block (ACB) Only | Pain Scores | 48 hours post-op | 40.2 units on a scale | Standard Error 4.66 |
| Adductor Canal Block (ACB) Only | Pain Scores | 12 hours post-op | 37.9 units on a scale | Standard Error 4.22 |
| Adductor Canal Block (ACB) Only | Pain Scores | 72 hours post-op | 36.2 units on a scale | Standard Error 4.8 |
| Adductor Canal Block (ACB) Only | Pain Scores | 24 hours post-op | 38.7 units on a scale | Standard Error 4.05 |
| Adductor Canal Block (ACB) Only | Pain Scores | 36 hours post-op | 40.9 units on a scale | Standard Error 4.84 |
| ACB + iPACK | Pain Scores | 24 hours post-op | 49.9 units on a scale | Standard Error 4.32 |
| ACB + iPACK | Pain Scores | 36 hours post-op | 54.7 units on a scale | Standard Error 4.35 |
| ACB + iPACK | Pain Scores | 48 hours post-op | 50.8 units on a scale | Standard Error 4.68 |
| ACB + iPACK | Pain Scores | 60 hours post-op | 44.2 units on a scale | Standard Error 4.2 |
| ACB + iPACK | Pain Scores | 72 hours post-op | 36.7 units on a scale | Standard Error 4.15 |
| ACB + iPACK | Pain Scores | Pain at Discharge | 29.8 units on a scale | Standard Error 20.5 |
| ACB + iPACK | Pain Scores | 12 hours post-op | 47.4 units on a scale | Standard Error 4.02 |
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.
Time frame: up to two months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adductor Canal Block (ACB) Only | Range of Motion (Degrees) | 90.0 degrees | Standard Error 2.38 |
| ACB + iPACK | Range of Motion (Degrees) | 99.3 degrees | Standard Error 2.23 |
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.
Time frame: up to 72 hours post-op
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adductor Canal Block (ACB) Only | Total Postoperative Opioid Consumption (Total MME) | 12 hours post-op | 8.26 morphine milligram equivalents | Standard Error 1.99 |
| Adductor Canal Block (ACB) Only | Total Postoperative Opioid Consumption (Total MME) | 24 hours post-op | 6.09 morphine milligram equivalents | Standard Error 1.98 |
| Adductor Canal Block (ACB) Only | Total Postoperative Opioid Consumption (Total MME) | 36 hours post-op | 10.4 morphine milligram equivalents | Standard Error 2.48 |
| Adductor Canal Block (ACB) Only | Total Postoperative Opioid Consumption (Total MME) | 48 hours post-op | 6.51 morphine milligram equivalents | Standard Error 2.15 |
| Adductor Canal Block (ACB) Only | Total Postoperative Opioid Consumption (Total MME) | 60 hours post-op | 10.5 morphine milligram equivalents | Standard Error 2.52 |
| Adductor Canal Block (ACB) Only | Total Postoperative Opioid Consumption (Total MME) | 72 hours post-op | 6.65 morphine milligram equivalents | Standard Error 2.18 |
| ACB + iPACK | Total Postoperative Opioid Consumption (Total MME) | 60 hours post-op | 14.5 morphine milligram equivalents | Standard Error 2.55 |
| ACB + iPACK | Total Postoperative Opioid Consumption (Total MME) | 12 hours post-op | 11.2 morphine milligram equivalents | Standard Error 1.93 |
| ACB + iPACK | Total Postoperative Opioid Consumption (Total MME) | 48 hours post-op | 10.5 morphine milligram equivalents | Standard Error 2.43 |
| ACB + iPACK | Total Postoperative Opioid Consumption (Total MME) | 24 hours post-op | 10.5 morphine milligram equivalents | Standard Error 2.05 |
| ACB + iPACK | Total Postoperative Opioid Consumption (Total MME) | 72 hours post-op | 7.65 morphine milligram equivalents | Standard Error 2.66 |
| ACB + iPACK | Total Postoperative Opioid Consumption (Total MME) | 36 hours post-op | 16.2 morphine milligram equivalents | Standard Error 2.97 |