Anterior Cruciate Ligament Pain Study

Study Overview
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Brief Summary
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The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.

Detailed Description
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This trial is a prospective, randomized, surgeon-blinded, two-armed trial to investigate the safety and efficacy of femoral nerve blocks versus adductor canal blocks for participants undergoing outpatient anterior cruciate ligament (ACL) reconstruction surgery. The objective of this study is to compare the pain control benefit of two different types of nerve blocks. Ropivacaine, which is FDA-approved for use in both femoral nerve blocks as well as adductor canal blocks, will be utilized. The study will be comparing the efficacy between FDA approved treatments.

Official Title
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Comparison Between Femoral Nerve Block and Adductor Canal Block for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Drug: Ropivacaine 0.5%
* Drug: Percocet 7.5/325
* Drug: Naprosyn 500 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center Patients willing and able to provide written informed consent Parents willing and able to provide written informed consent for minors Exclusion Criteria: Patients who are pregnant or lactating Patients with liver dysfunction or renal failure Patients with a known allergy to ropivacaine Patients with a local infection Patients who take chronic pain medications Patients with an opioid tolerance Patients with known coagulopathy or bleeding risk. Patients who are getting neuraxial anesthesia for surgery
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Femoral Nerve Block<br>Subjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery. | Drug: Ropivacaine 0.5%<br>* Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.<br>Drug: Percocet 7.5/325<br>* Percocet 7.5/325 will taken as needed up to every four hours.<br>Drug: Naprosyn 500 mg<br>* Naprosyn 500 mg will be taken twice daily.<br>|
| Active Comparator: Adductor Canal Block<br>Subjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery. | Drug: Ropivacaine 0.5%<br>* Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.<br>Drug: Percocet 7.5/325<br>* Percocet 7.5/325 will taken as needed up to every four hours.<br>Drug: Naprosyn 500 mg<br>* Naprosyn 500 mg will be taken twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry. | Post-surgery (day of surgery to 6 days post-surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Percocet Tablets Consumed | Participants recorded the total number of Percocet 7.5/325 (acetaminophen and oxycodone) tablets they took every day, in order to assess post-surgical use of opioids between the study arms, | Post surgery, Day 0 to Day 6 | 
| Total Hours of Sleep | The total hours of sleep first postoperative night, between 0 to 12 hours. | First Postoperative Night (up to 12 hours) | 
| Patient-Reported Nausea | Total occurrences of patient-reported nausea post-surgery. | Post-Surgery (up to 6 days) | 
| Patient-Reported Vomiting | Total occurrences of patient-reported vomiting post-surgery. | Post-Surgery (up to 6 days) | 
| Patient-Reported Constipation | Total occurrences of patient-reported constipation post-surgery. | Post-Surgery (up to 6 days) | 
| Patient-Reported Sedation | Total occurrences of patient-reported feelings of sedation post-surgery. | Post-Surgery (up to 6 days) | 
| Patient-Reported Itching | Total occurrences of patient-reported itching post-surgery. | Post-Surgery (up to 6 days) | 
| Time to Straight Less Raise | The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery. | Post-Surgery (up to 6 days) | 
| Percent of Patients Rating Their Satisfaction as Excellent or Good | Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery. | 2 Weeks Post-Surgery |