search
Back to results

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

Primary Purpose

Post-operative Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivicaine
placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring Post-operative pain, Anterior Cruciate Ligament repair

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 30, 2013
Last Updated
June 17, 2016
Sponsor
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT01916590
Brief Title
Effectiveness of Continuous Femoral Nerve Block Versus Single Shot Femoral Nerve Block for Pain Control
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of patients
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
Post-operative pain, Anterior Cruciate Ligament repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Bupivicaine
Intervention Description
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 Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Pain Scores Will be Collected for 48 Hours After ACL Reconstruction
Description
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
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Fiegel, M.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs