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All patients over the age of 16 undergoing primary or revision anterior cruciate ligament reconstruction with the use of bone-patellar-bone autograft are eligible for the study. Patients will be randomized pre-operatively to receive either an adductor canal nerve block (single injection) or a femoral nerve block (single injection). Post-operatively, the primary outcome measures of pain level using visual analog scale as well as narcotic and non-narcotic analgesic requirements will be measured.
Currently, because of its good track record, femoral nerve block is the modality of choice for post-operative pain control following elective anterior cruciate ligament reconstruction at our institution. It has been proven in the literature to provide good post-operative pain analgesia following this procedure (1). However, femoral nerve block is not without its concerns, including the concern for long-term quadriceps weakness (2). Benefits of decreased use of Femoral Nerve Block include the decreased incidence of side effects and/or complications, and use of quadriceps for immediate rehabilitation. Benefits of Adductor canal nerve block include possible equivalent pain control with the avoidance of motor de-innervation and its deleterious adverse effect of quadriceps weakness postoperatively. Adductor canal nerve block has proven to be effective in other orthopaedic procedures involving the knee including total knee arthroplasty (3). This results of this study will give more information on how to better control pain in the post-op period while minimizing the deleterious side effects for patients undergoing ACLreconstruction.
All patients over the age of 16 undergoing primary or revision anterior cruciate ligament reconstruction with the use of bone-patellar-bone autograft are eligible for the study. Patients will be randomized pre-operatively to receive either an adductor canal nerve block (single injection) or a femoral nerve block (single injection). A single dose of 30 mL of 0.25% marcaine is injected for femoral nerve block and 20 mL of 0.25% marcaine for Adductor Canal nerve block. These procedures will be performed by the attending anesthesiologist prior to surgery. After surgery the patient will record their pain levels using visual analog scale (VAS) score in a daily diary for the first 5 post-operative days. They will also record all medication requirements, both narcotic and non-narcotic analgesic medications. The patient will be tested on their ability to perform a straight leg raise in the post-anesthesia care unit (PACU) and at their first post-operative visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adductor Canal Nerve Block | Active Comparator | One hour prior to procedure, subject to receive 20 mL of 0.5% ropivacaine injected into the sheath of the saphenous nerve at the adductor hiatus. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure. |
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| Femoral Nerve block | Active Comparator | One hour prior to procedure, subject to receive 30 mL of 0.5% ropivacaine injected into the nerve sheath of the femoral nerve at the level of the femoral triangle. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marcaine 0.25 % Injectable Solution | Drug | For the adductor canal block, 20 mL of 0.25% marcaine will be injected with the use of ultrasound guidance into the adductor canal by the attending anesthesiologist on the case in the pre-op holding area. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Level Per Arm on the Visual Analog Scale (VAS) at Post-operative (Day 0), Day 1, Day 2, Day 3. | The VAS is a validated self-reported instrument for measuring pain intensity. Possible scores range from 0 (no pain) to 10 (worse possible pain). | Post-operative Day 0, Day 1, Day 2, Day 3 |
| Average Narcotic Consumption Per Arm in Morphine Equivalents at Post-operative (Day 0), Day 1, Day 2, Day 3. | Norco 5-325 (hydrocodone with acetaminophen) oral tablet prescribed (1-2 tablets every 4-6 hours as needed for pain) converted to intravenous morphine equivalent dosing. | Post-operative Day 0, Day 1, Day 2, Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System - CFP 642 | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24565346 | Background | Guirro UB, Tambara EM, Munhoz FR. Femoral nerve block: Assessment of postoperative analgesia in arthroscopic anterior cruciate ligament reconstruction. Braz J Anesthesiol. 2013 Nov-Dec;63(6):483-91. doi: 10.1016/j.bjane.2013.09.001. Epub 2013 Dec 5. | |
| 25466410 | Background | Luo TD, Ashraf A, Dahm DL, Stuart MJ, McIntosh AL. Femoral nerve block is associated with persistent strength deficits at 6 months after anterior cruciate ligament reconstruction in pediatric and adolescent patients. Am J Sports Med. 2015 Feb;43(2):331-6. doi: 10.1177/0363546514559823. Epub 2014 Dec 2. |
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Eighty-six patients undergoing Anterior Cruciate Ligament (ACL) reconstruction with Bone to Bone (BTB) autograft were assessed for eligibility during the time period. Seventy-eight patients were consented to participate in the study, randomized, and received the appropriate treatment block.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adductor Canal Nerve Block | One hour prior to procedure, subject to receive 20 mL of 0.5% ropivacaine injected into the sheath of the saphenous nerve at the adductor hiatus. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure. Marcaine 0.25 % Injectable Solution: For the adductor canal block, 20 mL of 0.25% marcaine will be injected with the use of ultrasound guidance into the adductor canal by the attending anesthesiologist on the case in the pre-op holding area. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Apr 24, 2018 |
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| Marcaine 0.25 % Injectable Solution | Drug | For the femoral nerve block, 30 mL of 0.25% marcaine will be injected with the use of ultrasound guidance around the femoral nerve sheath by the attending anesthesiologist on the case in the pre-op holding area. |
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| 24401769 | Background | Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119. |
| 30557034 | Derived | Lynch JR, Okoroha KR, Lizzio V, Yu CC, Jildeh TR, Moutzouros V. Adductor Canal Block Versus Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial. Am J Sports Med. 2019 Feb;47(2):355-363. doi: 10.1177/0363546518815874. Epub 2018 Dec 17. |
| FG001 | Femoral Nerve Block | One hour prior to procedure, subject to receive 30 mL of 0.5% ropivacaine injected into the nerve sheath of the femoral nerve at the level of the femoral triangle. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure. Marcaine 0.25 % Injectable Solution: For the femoral nerve block, 30 mL of 0.25% marcaine will be injected with the use of ultrasound guidance around the femoral nerve sheath by the attending anesthesiologist on the case in the pre-op holding area. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adductor Canal Nerve Block | One hour prior to procedure, subject to receive 20 mL of 0.5% ropivacaine injected into the sheath of the saphenous nerve at the adductor hiatus. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure. Marcaine 0.25 % Injectable Solution: For the adductor canal block, 20 mL of 0.25% marcaine will be injected with the use of ultrasound guidance into the adductor canal by the attending anesthesiologist on the case in the pre-op holding area. |
| BG001 | Femoral Nerve Block | One hour prior to procedure, subject to receive 30 mL of 0.5% ropivacaine injected into the nerve sheath of the femoral nerve at the level of the femoral triangle. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure. Marcaine 0.25 % Injectable Solution: For the femoral nerve block, 30 mL of 0.25% marcaine will be injected with the use of ultrasound guidance around the femoral nerve sheath by the attending anesthesiologist on the case in the pre-op holding area. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Eighteen participants enrolled did not complete the pain diary and were not included in the analysis. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Eighteen participants did not complete the pain diary and were not included in the analysis. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Eighteen participants did not complete the pain diary and were not included in the analysis. | Number | participants |
| |||||||||||||||
| Body Mass Index | Eighteen participants did not complete the pain diary and were not included in the analysis. | Mean | Standard Deviation | kg/m^2 |
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| 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 | Average Pain Level Per Arm on the Visual Analog Scale (VAS) at Post-operative (Day 0), Day 1, Day 2, Day 3. | The VAS is a validated self-reported instrument for measuring pain intensity. Possible scores range from 0 (no pain) to 10 (worse possible pain). | Eighteen participants enrolled in the study did not complete the pain diary and were not included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Post-operative Day 0, Day 1, Day 2, Day 3 |
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| Primary | Average Narcotic Consumption Per Arm in Morphine Equivalents at Post-operative (Day 0), Day 1, Day 2, Day 3. | Norco 5-325 (hydrocodone with acetaminophen) oral tablet prescribed (1-2 tablets every 4-6 hours as needed for pain) converted to intravenous morphine equivalent dosing. | Eighteen participants enrolled did not complete the pain diary and were not included in the analysis. | Posted | Mean | Standard Deviation | milligrams of morphine equivalent | Post-operative Day 0, Day 1, Day 2, Day 3 |
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Consent through Day 3 post operative.
Eighteen participants enrolled in the study did not complete the pain diary and were not analyzed.
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| 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 Nerve Block | One hour prior to procedure, subject to receive 20 mL of 0.5% ropivacaine injected into the sheath of the saphenous nerve at the adductor hiatus. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure. Marcaine 0.25 % Injectable Solution: For the adductor canal block, 20 mL of 0.25% marcaine will be injected with the use of ultrasound guidance into the adductor canal by the attending anesthesiologist on the case in the pre-op holding area. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | Femoral Nerve Block | One hour prior to procedure, subject to receive 30 mL of 0.5% ropivacaine injected into the nerve sheath of the femoral nerve at the level of the femoral triangle. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure. Marcaine 0.25 % Injectable Solution: For the femoral nerve block, 30 mL of 0.25% marcaine will be injected with the use of ultrasound guidance around the femoral nerve sheath by the attending anesthesiologist on the case in the pre-op holding area. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Office Manager | Henry Ford Health | 313-953-7454 | smarl1@hfhs.org |
| Apr 30, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 19, 2016 | Mar 23, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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