Effectiveness of Continuous Femoral Nerve Block Versus Single Shot Femoral Nerve Block for Pain Control

This study has been terminated.
(lack of patients)
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01916590
First received: July 30, 2013
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Post-operative Pain
Drug: Bupivicaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Pain scores will be collected for 48 hours after ACL reconstruction [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]
    Pain scores will be collected for 48 hours after ACL reconstruction with patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block.


Secondary Outcome Measures:
  • Doses of pain medications taken will be collected for 48 hours after ACL reconstruction. [ Time Frame: First 48 hours after surgery ] [ Designated as safety issue: No ]
    Dose of pain medications will be collected for 48 hours after ACL reconstruction with patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block.

  • Patient satisfaction will be collected for 48 hours after ACL reconstruction. [ Time Frame: First 48 hours after surgery ] [ Designated as safety issue: No ]
    Patient satisfaction will be collected for 48 hours after ACL reconstruction with patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block.


Enrollment: 7
Study Start Date: July 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Bupivicaine
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.
Placebo Comparator: 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.

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 our knowledge, no study has compared these two techniques after ACLR with patellar tendon graft or allograft.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Localized infection of the groin or generalized sepsis.
  2. Hypersensitivity or known allergy to local anesthetics.
  3. Preexisting nerve damage in surgical limb.
  4. 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.
  5. Patients who elect to have knee surgery under spinal anesthesia or who cannot undergo general anesthetic.
  6. Patients who decline to have a femoral nerve block with catheter.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01916590

Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Matthew Fiegel, M.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01916590     History of Changes
Other Study ID Numbers: 11-0847
Study First Received: July 30, 2013
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Post-operative pain
Anterior Cruciate Ligament repair

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014