Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adductor Canal Block (ACB) | Active Comparator | 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. |
|
| Adductor Canal Block & IPACK (ACB/IPACK) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivacaine will help treat pain and sensation after ACL repair |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Beathe, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10023 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | some patients were lost to follow up | Posted | Mean | Standard Deviation | score on a scale | 24 hours post-block administration |
|
up to 7 days after surgery
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Beathe | Hospital for Special Surgery, Anesthesiology | 2126061036 | beatheJ@hss.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2019 | Apr 12, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D014463 | Ultrasonography |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ultrasound | Device | Ultrasound will guide anesthesiologist in performing the different nerve blocks |
|
| Dexamethasone | Drug | Dexamethasone will be used to prolong block duration |
|
|
| 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| 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. | some patients lost to follow up | Posted | Mean | Standard Deviation | minutes | From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day |
|
|
|
| Secondary | Pain With Ambulation | NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10. | Posted | Mean | Standard Deviation | score on a scale | 3 hours post-block administration on Post-operative day (POD) 0 |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | 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 | 0 | 39 | 0 | 39 | 0 | 39 |
Not provided
Not provided
Not provided
| D000588 |
| Amines |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |