Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction

NCT00022854 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2013-05-03

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Rupture

Interventions

PROCEDURE

Single-injection femoral nerve block

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

PROCEDURE

Femoral 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

PROCEDURE

Saline (control) injection into femoral nerve envelope

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

Sponsors & Collaborators

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

    collaborator NIH
  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Brian A. Williams, MD, MBA · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Completion
2005-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00022854 on ClinicalTrials.gov