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

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

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.

Study Overview

• Status: Terminated
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: placebo; Drug: Bupivicaine

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores Will be Collected for 48 Hours After ACL Reconstruction	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	48 hours after surgery

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Matthew Fiegel, M.D., University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: August 3, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Estimate): August 1, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Post-operative pain; Anterior Cruciate Ligament repair
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 11-0847