Clinical Trial: Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction

This study has been completed.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

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.

Condition Treatment or Intervention Phase
Anterior Cruciate Ligament Rupture
 Procedure: Single-injection femoral nerve block
 Procedure: Femoral nerve block 60-hour continuous injection
 Procedure: Saline (control) injection into femoral nerve envelope
Phase IV

MedlinePlus related topics:  Muscle Disorders;   Sprains and Strains

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  270

Study start: May 2001;  Study completion: February 2006

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.

Eligibility

Ages Eligible for Study:  14 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

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

Location Information


Pennsylvania
      University of Pittsburgh Medical Center, Center for Sports Medicine, Pittsburgh,  Pennsylvania,  15203,  United States

Study chairs or principal investigators

Brian A. Williams, MD, MBA,  Principal Investigator,  University of Pittsburgh   

More Information

Publications

Williams BA, Kentor ML, Williams JP, Figallo CM, Sigl JC, Anders JW, Bear TC, Tullock WC, Bennett CH, Harner CD, Fu FH. Process analysis in outpatient knee surgery: effects of regional and general anesthesia on anesthesia-controlled time. Anesthesiology. 2000 Aug;93(2):529-38.

Williams BA, Kentor ML, Williams JP, Vogt MT, DaPos SV, Harner CD, Fu FH. PACU bypass after outpatient knee surgery is associated with fewer unplanned hospital admissions but more phase II nursing interventions. Anesthesiology. 2002 Oct;97(4):981-8.

Williams BA, Kentor ML, Vogt MT, Williams JP, Chelly JE, Valalik S, Harner CD, Fu FH. Femoral-sciatic nerve blocks for complex outpatient knee surgery are associated with less postoperative pain before same-day discharge: a review of 1,200 consecutive cases from the period 1996-1999. Anesthesiology. 2003 May;98(5):1206-13.

Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706.

Study ID Numbers:  NIAMS-066; K23 AR47631
Record last reviewed:  March 2005
Last Updated:  March 2, 2005
Record first received:  August 14, 2001
ClinicalTrials.gov Identifier:  NCT00022854
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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