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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous infusion (5 mL/hr for 50 hours) of 0.25% levobupivacaine
Nerve block bolus with 30 mL saline, followed by continuous saline infusion
University of Pittsburgh Medical Center, Center for Sports Medicine
Pittsburgh, Pennsylvania, United States
Pain scores during the first week after surgery
Time frame: one week
Side effects during the first week after surgery (nausea, vomiting, quality of sleep)
Time frame: first week after surgery
Determine the "rebound pain score" after a nerve block wears off
Time frame: first week after surgery
Skin reactions to the nerve block catehter dressing
Time frame: first week after surgery
Risk of falling
Time frame: first week after surgery
Validation of an 8-item outcome survey in comparison to a 40-item "gold standard" outcome survey
Time frame: first week after surgery
Study staffing costs before and after the implementation of HIPAA
Time frame: the 40 months of study recruitment
Patient-reported general health status, and patient-reported knee function, during the first 12 weeks after surgery
Time frame: up to 12 weeks after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.