Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00022854
First received: August 14, 2001
Last updated: May 2, 2013
Last verified: May 2013
  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 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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcomes After ACL Reconstruction: The Effect of Femoral Nerve Block Analgesia

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Pain scores during the first week after surgery [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects during the first week after surgery (nausea, vomiting, quality of sleep) [ Time Frame: first week after surgery ] [ Designated as safety issue: No ]
  • Determine the "rebound pain score" after a nerve block wears off [ Time Frame: first week after surgery ] [ Designated as safety issue: No ]
  • Skin reactions to the nerve block catehter dressing [ Time Frame: first week after surgery ] [ Designated as safety issue: Yes ]
  • Risk of falling [ Time Frame: first week after surgery ] [ Designated as safety issue: Yes ]
  • Validation of an 8-item outcome survey in comparison to a 40-item "gold standard" outcome survey [ Time Frame: first week after surgery ] [ Designated as safety issue: No ]
  • Study staffing costs before and after the implementation of HIPAA [ Time Frame: the 40 months of study recruitment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: May 2001
Study Completion Date: January 2005
Arms Assigned Interventions
Placebo Comparator: 1 Procedure: Saline (control) injection into femoral nerve envelope
Nerve block bolus with 30 mL saline, followed by continuous saline infusion
Experimental: 2
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion
Procedure: Single-injection femoral nerve block
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion
Experimental: 3
Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous levobupivacaine infusion of 5 mL/hr for 50 hr
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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022854

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center, Center for Sports Medicine
Pittsburgh, Pennsylvania, United States, 15203
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Brian A. Williams, MD, MBA University of Pittsburgh
  More Information

Publications:

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00022854     History of Changes
Other Study ID Numbers: K23 AR47631, K23AR047631, NIAMS-066
Study First Received: August 14, 2001
Last Updated: May 2, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
ACL
Nerve block
Knee
Outcome survey
Anesthesia
Analgesia
Pain

Additional relevant MeSH terms:
Levobupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014