Anterior Cruciate Ligament Injury
Conditions
Brief summary
A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.
Interventions
DRUGBupivacaine
Bupivacaine will help treat pain and sensation after ACL repair
DEVICEUltrasound
Ultrasound will guide anesthesiologist in performing the different nerve blocks
DRUGDexamethasone
Dexamethasone will be used to prolong block duration
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing BTB ACL reconstruction with participating surgeon * Age 13 or greater * Planned use of regional anesthesia * Ability to follow study protocol * English speaking (secondary outcomes include questionnaires validated in English only)
Exclusion criteria
* Hepatic or renal insufficiency * Younger than 13 years old * Patients undergoing general anesthesia * Allergy or intolerance to one of the study medications * BMI \> 40 * Diabetes * American Society of Anesthesiology (ASA) score IV * Chronic gabapentin/pregabalin use (regular use for longer than 3 months) * Chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of \>5mg/day for one month) * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain While at Rest | 24 hours post-block administration | Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discharge Criteria | From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day | Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin. |
| Pain With Ambulation | 3 hours post-block administration on Post-operative day (POD) 0 | NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adductor Canal Block (ACB) The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration | 39 |
| Adductor Canal Block & IPACK (ACB/IPACK) The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone: Dexamethasone will be used to prolong block duration | 39 |
| Total | 78 |
Baseline characteristics
| Characteristic | Adductor Canal Block (ACB) | Total | Adductor Canal Block & IPACK (ACB/IPACK) |
|---|---|---|---|
| Age, Continuous | 23 years STANDARD_DEVIATION 7 | 24 years STANDARD_DEVIATION 7 | 25 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 10 Participants | 5 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 | 4 Participants | 12 Participants | 8 Participants |
| Race (NIH/OMB) White | 26 Participants | 46 Participants | 20 Participants |
| Region of Enrollment United States | 39 participants | 78 participants | 39 participants |
| Sex: Female, Male Female | 13 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Male | 26 Participants | 53 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
Pain While at Rest
Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
Time frame: 24 hours post-block administration
Population: some patients were lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adductor Canal Block (ACB) | Pain While at Rest | 3.84 score on a scale | Standard Deviation 1.86 |
| Adductor Canal Block & IPACK (ACB/IPACK) | Pain While at Rest | 3.95 score on a scale | Standard Deviation 2.58 |
Secondary
Discharge Criteria
Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.
Time frame: From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day
Population: some patients lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adductor Canal Block (ACB) | Discharge Criteria | 180.67 minutes | Standard Deviation 143.84 |
| Adductor Canal Block & IPACK (ACB/IPACK) | Discharge Criteria | 189.92 minutes | Standard Deviation 254.55 |
Secondary
Pain With Ambulation
NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10.
Time frame: 3 hours post-block administration on Post-operative day (POD) 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adductor Canal Block (ACB) | Pain With Ambulation | NRS with Ambulation | 1.59 score on a scale | Standard Deviation 1.43 |
| Adductor Canal Block (ACB) | Pain With Ambulation | NRS with Stairs | 2.05 score on a scale | Standard Deviation 1.92 |
| Adductor Canal Block & IPACK (ACB/IPACK) | Pain With Ambulation | NRS with Ambulation | 1.26 score on a scale | Standard Deviation 1.23 |
| Adductor Canal Block & IPACK (ACB/IPACK) | Pain With Ambulation | NRS with Stairs | 2.1 score on a scale | Standard Deviation 1.81 |