Anterior Cruciate Ligament Rupture
Conditions
Keywords
ACL, Nerve block, Knee, Outcome survey, Anesthesia, Analgesia, Pain
Brief summary
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
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.
Interventions
PROCEDUREFemoral nerve block 60-hour continuous injection
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous infusion (5 mL/hr for 50 hours) of 0.25% levobupivacaine
PROCEDURESingle-injection femoral nerve block
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion
PROCEDURESaline (control) injection into femoral nerve envelope
Nerve block bolus with 30 mL saline, followed by continuous saline infusion
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain scores during the first week after surgery | one week |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Side effects during the first week after surgery (nausea, vomiting, quality of sleep) | 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 |
| Validation of an 8-item outcome survey in comparison to a 40-item gold standard outcome survey | first week after surgery |
Countries
United States
Outcome results
None listed