Home | | | Search | | | Browse | | | Resources | | | Help | | | What's New | | | About |
---|
Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction
This study is currently recruiting patients.
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: 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
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:
Exclusion Criteria:
Location and Contact Information
More Information
Publications
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
Copyright, Privacy, Accessibility, Freedom of Information Act |