ACL Surgery
Conditions
Brief summary
This is a prospective, randomized, single blinded trial involving human subjects. The goal of this study is to determine an optimal location (proximal or distal) for the nerve block and whether it will make a difference in how much opioid the patient will receive during and after surgery. Ultrasound will identify the adductor canal and the proximal end of the adductor canal/apex of the femoral triangle to determine the location of the blocks. Their will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB proximal to true AC with bupivacaine 0.5% 20cc
Interventions
DRUGACB within true AC with bupivacaine 0.5% 20cc
The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.
DRUGACB proximal to true AC with bupivacaine 0.5% 20cc
Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing unilateral, ACL surgery with allograft. * Patients who consent to be randomized. * Patients must be English proficient.
Exclusion criteria
* Patients younger than 18 or older than 75 years of age; * Patients with a history of chronic pain or who are taking medications intended to treat chronic pain such as strong opioids; * Patients with history of neurologic disorder that can interfere with pain sensation; * Patients with a history of drug or alcohol abuse; * Patients who are unable to understand or follow instructions; * Patients with an allergy or a contraindication to any of the medications used in the study, or patients with a contraindication to any of the study procedures; * Patients with severe liver disease, renal insufficiency, congestive heart failure, and/ or significant heart disease; * Patients with a BMI over 42; * Any patient that the investigators feel cannot comply with all study related procedures. * Patients who do not tolerate Percocet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents | 24 Hours | Amount of morphine equivalents administered intraoperatively in 24 hours |
| Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents | 24 Hours | Amount of morphine equivalents administered postoperatively in 24 hours |
| Side Effects Such as Nausea, Itching, Constipation. | 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months. | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACB Within True AC With Bupivacaine The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine
ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block. | 33 |
| ACB Proximal to True AC With Bupivacaine The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine
ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine | 36 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Anesthesia plan changed | 2 | 2 |
| Overall Study | Cancelled surgery | 0 | 2 |
| Overall Study | Did not complete medication diary | 4 | 2 |
| Overall Study | Lost to Follow-up | 4 | 6 |
| Overall Study | post surgery medication change | 2 | 1 |
Baseline characteristics
| Characteristic | ACB Proximal to True AC With Bupivacaine | ACB Within True AC With Bupivacaine | Total |
|---|---|---|---|
| Age, Customized 18-25 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Customized 26-35 years | 15 Participants | 13 Participants | 28 Participants |
| Age, Customized 36-45 years | 7 Participants | 3 Participants | 10 Participants |
| Age, Customized 46-55 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Customized 56-65 years | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 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 | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) White | 21 Participants | 23 Participants | 44 Participants |
| Region of Enrollment United States | 36 participants | 33 participants | 69 participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 31 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 23 |
| other Total, other adverse events | 0 / 20 | 0 / 23 |
| serious Total, serious adverse events | 0 / 20 | 0 / 23 |
Outcome results
Primary
Side Effects Such as Nausea, Itching, Constipation.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ACB Within True AC With Bupivacaine | Side Effects Such as Nausea, Itching, Constipation. | 0 Participants |
| ACB Proximal to True AC With Bupivacaine | Side Effects Such as Nausea, Itching, Constipation. | 0 Participants |
Primary
Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents
Amount of morphine equivalents administered intraoperatively in 24 hours
Time frame: 24 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACB Within True AC With Bupivacaine | Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents | 23.21 milligrams of morphine equivalents | Standard Deviation 12.23 |
| ACB Proximal to True AC With Bupivacaine | Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents | 18.93 milligrams of morphine equivalents | Standard Deviation 9.34 |
Primary
Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents
Amount of morphine equivalents administered postoperatively in 24 hours
Time frame: 24 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACB Within True AC With Bupivacaine | Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents | 10 mg of morphine equivalents | Standard Deviation 6.79 |
| ACB Proximal to True AC With Bupivacaine | Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents | 13.18 mg of morphine equivalents | Standard Deviation 7.57 |
Secondary
Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months.
Time frame: 12 months
Population: This measure was not measured/assessed in study participants; the orthopedic surgeon's office did not perform this test in the clinic at any point of the study.