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Clinical Trials/NCT01916590
NCT01916590
Terminated
Not Applicable

Effectiveness of Continuous Femoral Nerve Block Versus Single Shot Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction With Patellar Tendon Graft or Allograft

University of Colorado, Denver1 site in 1 country7 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Bupivicaine
Conditions
Post-operative Pain
Sponsor
University of Colorado, Denver
Enrollment
7
Locations
1
Primary Endpoint
Pain Scores Will be Collected for 48 Hours After ACL Reconstruction
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

Both single shot femoral nerve block and continuous femoral nerve block with catheter have been shown to be effective for pain control after anterior cruciate ligament reconstruction (ACLR). Continuous femoral nerve block may be the more effective of the two in reducing pain scores and opioid consumption for the first 48 hours postoperatively.

Detailed Description

The number of ambulatory procedures has steadily increased over the last decade. Postoperative pain is the most common cause of delayed discharge and unexpected admission after ambulatory surgery. Knee surgery was identified as one of the procedures associated with the most pain at 24 hours, with a 45% or higher incidence of moderate or severe pain. Poor pain control can counteract many of the benefits of ambulatory surgery and can lead to the development of chronic pain. Regional techniques have been shown to be effective after ACL reconstruction, allowing faster patient recovery with fewer side-effects than intravenous administration of opioids. Different regional techniques have been applied and studied after ACLR. Femoral nerve block for ACLR either as a single bolus or as a continuous infusion markedly decreases intravenous analgesic requirements and postoperative pain. To the Investigator's knowledge, no study has compared these two techniques after ACLR with patellar tendon graft or allograft.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
May 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists score between 1-3
  • Scheduled to undergo Anterior Cruciate Ligament reconstruction with patellar tendon graft or allograft under general anesthesia

Exclusion Criteria

  • Localized infection of the groin or generalized sepsis.
  • Hypersensitivity or known allergy to local anesthetics.
  • Preexisting nerve damage in surgical limb.
  • History of chronic pain with either (a) daily opioid requirement exceeding the equivalent of 50 mg morphine or (b) daily prescription of tricyclic antidepressants, gabapentin, pregabalin, or tramadol for pain.
  • Patients who elect to have knee surgery under spinal anesthesia or who cannot undergo general anesthetic.
  • Patients who decline to have a femoral nerve block with catheter.

Arms & Interventions

Bupivacaine

All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.

Intervention: Bupivicaine

Placebo

All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.

Intervention: placebo

Outcomes

Primary Outcomes

Pain Scores Will be Collected for 48 Hours After ACL Reconstruction

Time Frame: 48 hours after surgery

Pain scores will be collected for 48 hours after ACL reconstruction with a patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block

Study Sites (1)

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