Anterior Cruciate Ligament Rupture Clinical Trial
Official title:
Outcomes After ACL Reconstruction: The Effect of Femoral Nerve Block Analgesia
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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