Anterior Cruciate Ligament Rupture
Conditions
Brief summary
A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft
Detailed description
The protocol will determine if the addition of an IPACK block to the standard adductor canal block is superior to an isolated adductor canal block in controlling post-operative pain and decreasing postoperative opioid consumption in patients undergoing ACLR with Bone Patellar Tendon Bone Autograft
Interventions
IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients between 18 and 75 years of age * Patients undergoing primary ACL reconstruction with BPTB Autograft * ASA I or II
Exclusion criteria
* Patients younger than 18 and older than 75. * Patients with multi-ligament injury * Patients undergoing concomitant cartilage procedure or osteotomy. * Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer. * Patients who are allergic to oxycodone; * Patients with diagnosed or self-reported cognitive dysfunction; * Patients with a history of neurologic disorder that can interfere with pain sensation; * Patients with a history of drug or recorded alcohol abuse; * Patients who are unable to understand or follow instructions; * Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease; * Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures; * Patients with a BMI over 45; * Any patient that the investigators feel cannot comply with all study related procedures; * Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Utilization in First 24 Hours Post-Surgery | Up to Hour 24 Post-Operation | Opioid utilization for the first 24 hours after surgery, including during surgery, is calculated as oral morphine equivalent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported VAS Scores at 48 Hours Post-Surgery | Hour 48 Post-Operation | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain. |
| Patient-Reported VAS Scores at 72 Hours Post-Surgery | Hour 72 Post-Operation | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain. |
| Patient-Reported VAS Scores at Day 7 Post-Surgery | Day 7 Post-Operation | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain. |
| Length of Stay in Post-Anesthesia Care Unit (PACU) | Up to Day 1 Post-Operation | Measured by the length of stay after surgery (minutes) |
| Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery | Hour 24 Post-Operation | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score ranges from 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain. |
| Change in Kujala Scale Score | Baseline, Month 6 Post-Operation Visit | Knee pain will be measured by self reported Kujala scale. The Kujala Scale is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). The total score ranges from 0 to 100; higher scores indicate lesser knee pain. |
| Change in Tegner Activity Scale (TAS) Score | Baseline, Month 6 Post-Operation Visit | The TAS asks participants to indicate the highest level of activity they are able to participate in at the time of the survey. The options range from Level 10 (competitive sports on a national elite level) to Level 0 (sick leave or disability pension because of knee problems). The total score corresponds with the selected Level and ranges from 0-10; higher scores indicate higher levels of activity. |
| Change of Range of Motion (ROM) Assessment | Baseline, Month 6 Post-Operation Visit | A Range of Motion (ROM) assessment is most commonly used to measure movement of the ankles, knees, hips, shoulders, elbows, wrists and fingers. Measures of knee ROM will be taken at baseline and Month 6 to assess the change in ROM over time. |
| Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS) | Baseline, Month 6 Post-Operation Visit | The KOOS-PS is a 7-item measure of physical functional derived from the items of the Function, daily living and Function, sports and recreational activity subscales of the KOOS. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The raw score is calculated by summing the responses and ranges from 0-28. The raw score is converted to a true interval score ranging from 0-100, where higher scores indicate greater physical function. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants Receiving IPACK Block Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee.
IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | 24 |
| Standard of Care Group Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). | 12 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discovery of multi-ligamentous injury intra-operatively | 0 | 1 |
| Overall Study | Incomplete outcome assessments | 2 | 1 |
| Overall Study | Lost to follow up at 6 months | 25 | 35 |
| Overall Study | Study medication not available | 1 | 1 |
Baseline characteristics
| Characteristic | Participants Receiving IPACK Block | Total | Standard of Care Group |
|---|---|---|---|
| Age, Continuous | 27.88 years STANDARD_DEVIATION 7.42 | 28.47 years STANDARD_DEVIATION 8.41 | 29.67 years STANDARD_DEVIATION 10.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 34 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 22 Participants | 8 Participants |
| Region of Enrollment United States | 24 participants | 36 participants | 12 participants |
| Sex: Female, Male Female | 11 Participants | 19 Participants | 8 Participants |
| Sex: Female, Male Male | 13 Participants | 17 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 50 |
| other Total, other adverse events | 0 / 52 | 0 / 50 |
| serious Total, serious adverse events | 0 / 52 | 0 / 50 |
Outcome results
Opioid Utilization in First 24 Hours Post-Surgery
Opioid utilization for the first 24 hours after surgery, including during surgery, is calculated as oral morphine equivalent.
Time frame: Up to Hour 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving IPACK Block | Opioid Utilization in First 24 Hours Post-Surgery | 6.1 morphine milligram equivalents | Standard Deviation 5.5 |
| Standard of Care Group | Opioid Utilization in First 24 Hours Post-Surgery | 10.7 morphine milligram equivalents | Standard Deviation 7.1 |
Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)
The KOOS-PS is a 7-item measure of physical functional derived from the items of the Function, daily living and Function, sports and recreational activity subscales of the KOOS. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The raw score is calculated by summing the responses and ranges from 0-28. The raw score is converted to a true interval score ranging from 0-100, where higher scores indicate greater physical function.
Time frame: Baseline, Month 6 Post-Operation Visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving IPACK Block | Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS) | 4.88 score on a scale | Standard Deviation 13.6 |
| Standard of Care Group | Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS) | 13.52 score on a scale | Standard Deviation 14.58 |
Change in Kujala Scale Score
Knee pain will be measured by self reported Kujala scale. The Kujala Scale is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). The total score ranges from 0 to 100; higher scores indicate lesser knee pain.
Time frame: Baseline, Month 6 Post-Operation Visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving IPACK Block | Change in Kujala Scale Score | 9.47 score on a scale | Standard Deviation 14.86 |
| Standard of Care Group | Change in Kujala Scale Score | 18.75 score on a scale | Standard Deviation 19.75 |
Change in Tegner Activity Scale (TAS) Score
The TAS asks participants to indicate the highest level of activity they are able to participate in at the time of the survey. The options range from Level 10 (competitive sports on a national elite level) to Level 0 (sick leave or disability pension because of knee problems). The total score corresponds with the selected Level and ranges from 0-10; higher scores indicate higher levels of activity.
Time frame: Baseline, Month 6 Post-Operation Visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving IPACK Block | Change in Tegner Activity Scale (TAS) Score | 1.25 score on a scale | Standard Deviation 1.11 |
| Standard of Care Group | Change in Tegner Activity Scale (TAS) Score | 1.92 score on a scale | Standard Deviation 1.83 |
Change of Range of Motion (ROM) Assessment
A Range of Motion (ROM) assessment is most commonly used to measure movement of the ankles, knees, hips, shoulders, elbows, wrists and fingers. Measures of knee ROM will be taken at baseline and Month 6 to assess the change in ROM over time.
Time frame: Baseline, Month 6 Post-Operation Visit
Population: No participants had data collected/were analyzed for the purposes of this outcome measure.
Length of Stay in Post-Anesthesia Care Unit (PACU)
Measured by the length of stay after surgery (minutes)
Time frame: Up to Day 1 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving IPACK Block | Length of Stay in Post-Anesthesia Care Unit (PACU) | 131.19 Minutes | Standard Deviation 50.47 |
| Standard of Care Group | Length of Stay in Post-Anesthesia Care Unit (PACU) | 131.22 Minutes | Standard Deviation 37.5 |
Patient-Reported VAS Scores at 48 Hours Post-Surgery
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: Hour 48 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving IPACK Block | Patient-Reported VAS Scores at 48 Hours Post-Surgery | 55.5 score on a scale | Standard Deviation 24.34 |
| Standard of Care Group | Patient-Reported VAS Scores at 48 Hours Post-Surgery | 64 score on a scale | Standard Deviation 22.6 |
Patient-Reported VAS Scores at 72 Hours Post-Surgery
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: Hour 72 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving IPACK Block | Patient-Reported VAS Scores at 72 Hours Post-Surgery | 44.4 score on a scale | Standard Deviation 23.83 |
| Standard of Care Group | Patient-Reported VAS Scores at 72 Hours Post-Surgery | 54.9 score on a scale | Standard Deviation 24.18 |
Patient-Reported VAS Scores at Day 7 Post-Surgery
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: Day 7 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving IPACK Block | Patient-Reported VAS Scores at Day 7 Post-Surgery | 36.3 score on a scale | Standard Deviation 23.02 |
| Standard of Care Group | Patient-Reported VAS Scores at Day 7 Post-Surgery | 42 score on a scale | Standard Deviation 24.17 |
Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score ranges from 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: Hour 24 Post-Operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Receiving IPACK Block | Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery | 55.2 score on a scale | Standard Deviation 18.8 |
| Standard of Care Group | Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery | 67.7 score on a scale | Standard Deviation 26.3 |