Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction

Study Overview
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Brief Summary
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Anterior cruciate ligament (ACL) reconstruction is surgery that is done to repair a damaged ligament in the knee. In this study we will look at whether the femoral nerve block, a commonly used method for pain relief after ACL reconstruction, affects the way patients feel after surgery. We will study recovery during the first week after surgery and also 3-12 weeks after surgery. We will give all patients spinal anesthesia. Some patients will also receive a continuous femoral nerve block for 2 days, or by a single injection. We predict that patients who received the nerve block will have significantly improved pain results, compared to patients who did not receive the nerve block.

Detailed Description
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In this project, we will measure outcomes of anesthesia and pain management for common orthopedic procedures. The influence of nerve block pain management on outcomes after outpatient anterior cruciate ligament (ACL) reconstruction has not been studied, especially the patient's potential to return to societal productivity during the first week after surgery. Therefore, we have designed a randomized clinical trial to study the role of nerve block pain management techniques on patient outcomes during the first week after surgery and on recovery 3-12 weeks after surgery. Our hypothesis is that patients undergoing nerve block analgesia will manifest better self-reported recovery outcomes, physical function outcomes, and objective measures of neuromuscular function. We will give consenting patients (n=270) undergoing ACL reconstruction conventional spinal anesthesia and will randomize them to receive femoral nerve block analgesia with either a single injection, a continuous infusion for 2 days, or saline placebo. We will use goniometry to test postoperative range of motion in extension to determine whether the quadriceps femoris torque output is impaired. We will compare patient-reported recovery outcomes across treatment groups using three validated health status measures suitable for daily assessment (Verbal Pain Score, SF-8, and the Quality of Recovery [from anesthesia, QoR-40] Score). We aim to determine the quality of immediate recovery from anesthesia and the extent of reported pain. We will compare the effects of single injection and continuous infusion on femoral nerve analgesia to determine the better dosing strategy for these patients.

Official Title
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Outcomes After ACL Reconstruction: The Effect of Femoral Nerve Block Analgesia

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Procedure: Single-injection femoral nerve block
* Procedure: Femoral nerve block 60-hour continuous injection
* Procedure: Saline (control) injection into femoral nerve envelope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 14-65 Undergoing ACL reconstruction at the University of Pittsburgh Agrees to spinal anesthesia and consents to one of the three nerve block interventions. Agrees to visit the University of Pittsburgh Center for Rehabilitation Services for postoperative physical therapy and rehabilitation (for standardized rehabilitation protocols) Exclusion Criteria: Morbid obesity Chronic pain syndromes Opioid dependence Corticosteroid prescriptions Tricyclic antidepressant prescriptions Tramadol prescriptions Preexisting neuropathies Poorly controlled diabetes mellitus Poorly controlled anxiety disorders

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Procedure: Saline (control) injection into femoral nerve envelope<br>* Nerve block bolus with 30 mL saline, followed by continuous saline infusion<br>|
| Experimental: 2<br>Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion | Procedure: Single-injection femoral nerve block<br>* Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion<br>|
| Experimental: 3<br>Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous levobupivacaine infusion of 5 mL/hr for 50 hr | Procedure: Femoral nerve block 60-hour continuous injection<br>* Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous infusion (5 mL/hr for 50 hours) of 0.25% levobupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores during the first week after surgery |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects during the first week after surgery (nausea, vomiting, quality of sleep) |  | first week after surgery | 
| Determine the rebound pain score after a nerve block wears off |  | first week after surgery | 
| Skin reactions to the nerve block catehter dressing |  | first week after surgery | 
| Risk of falling |  | first week after surgery | 
| Validation of an 8-item outcome survey in comparison to a 40-item gold standard outcome survey |  | first week after surgery | 
| Study staffing costs before and after the implementation of HIPAA |  | the 40 months of study recruitment | 
| Patient-reported general health status, and patient-reported knee function, during the first 12 weeks after surgery |  | up to 12 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, Nerve block, Knee, Outcome survey, Anesthesia, Analgesia, Pain