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NCT Number: NCT00022854

Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction

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.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Agnosia Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Wounds and Injuries

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh Medical Center, Center for Sports Medicine

Pittsburgh, Pennsylvania, 15203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-injection femoral nerve block

Procedure

Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion

Femoral nerve block 60-hour continuous injection

Procedure

Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous infusion (5 mL/hr for 50 hours) of 0.25% levobupivacaine

Saline (control) injection into femoral nerve envelope

Procedure

Nerve block bolus with 30 mL saline, followed by continuous saline infusion

Primary outcomes

  1. Pain scores during the first week after surgery

    Time frame: one week

Secondary outcomes

  1. Side effects during the first week after surgery (nausea, vomiting, quality of sleep)

    Time frame: first week after surgery

  2. Determine the "rebound pain score" after a nerve block wears off

    Time frame: first week after surgery

  3. Skin reactions to the nerve block catehter dressing

    Time frame: first week after surgery

  4. Risk of falling

    Time frame: first week after surgery

  5. Validation of an 8-item outcome survey in comparison to a 40-item "gold standard" outcome survey

    Time frame: first week after surgery

  6. Study staffing costs before and after the implementation of HIPAA

    Time frame: the 40 months of study recruitment

  7. 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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Outcomes After ACL Reconstruction: The Effect of Femoral Nerve Block Analgesia

Important dates

Study start
2001
Study completion
2005
First posted
Aug 16, 2001
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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