A Novel Analgesia Technique for ACL Reconstruction

Study Overview
=================
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.

Official Title
-----------------
A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block

Conditions
-----------------
Anterior Cruciate Ligament Injury

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Device: Ultrasound
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adductor Canal Block (ACB)<br>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. | Drug: Bupivacaine<br>* Bupivacaine will help treat pain and sensation after ACL repair<br>Device: Ultrasound<br>* Ultrasound will guide anesthesiologist in performing the different nerve blocks<br>Drug: Dexamethasone<br>* Dexamethasone will be used to prolong block duration<br>* Other names: preservative free Dexamethasone;|
| Active Comparator: Adductor Canal Block & IPACK (ACB/IPACK)<br>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. | Drug: Bupivacaine<br>* Bupivacaine will help treat pain and sensation after ACL repair<br>Device: Ultrasound<br>* Ultrasound will guide anesthesiologist in performing the different nerve blocks<br>Drug: Dexamethasone<br>* Dexamethasone will be used to prolong block duration<br>* Other names: preservative free Dexamethasone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain While at Rest | Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10. | 24 hours post-block administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day | 
| Pain With Ambulation | NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10. | 3 hours post-block administration on Post-operative day (POD) 0 |