Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Single-injection femoral nerve block; Femoral nerve block 60-hour continuous injection; Saline (control) injection into femoral nerve envelope
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ACL; Nerve block; Knee; Outcome survey; Anesthesia; Analgesia; Pain