Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction
- Conditions
- Anterior Cruciate Ligament Rupture
- Interventions
- Procedure: Saline (control) injection into femoral nerve envelopeProcedure: Single-injection femoral nerve blockProcedure: Femoral nerve block 60-hour continuous injection
- Registration Number
- NCT00022854
- Lead Sponsor
- University of Pittsburgh
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- 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)
- Morbid obesity
- Chronic pain syndromes
- Opioid dependence
- Corticosteroid prescriptions
- Tricyclic antidepressant prescriptions
- Tramadol prescriptions
- Preexisting neuropathies
- Poorly controlled diabetes mellitus
- Poorly controlled anxiety disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Saline (control) injection into femoral nerve envelope - 2 Single-injection femoral nerve block Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion 3 Femoral nerve block 60-hour continuous injection Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous levobupivacaine infusion of 5 mL/hr for 50 hr
- Primary Outcome Measures
Name Time Method Pain scores during the first week after surgery one week
- Secondary Outcome Measures
Name Time Method Determine the "rebound pain score" after a nerve block wears off first week after surgery Side effects during the first week after surgery (nausea, vomiting, quality of sleep) 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
Trial Locations
- Locations (1)
University of Pittsburgh Medical Center, Center for Sports Medicine
🇺🇸Pittsburgh, Pennsylvania, United States