Trial record 14 of 32 for:    Foot Drop

Continuous Femoral and Tibial Nerve Blocks in TKA Patients

This study is currently recruiting participants.
Verified October 2013 by Texas Tech University Health Sciences Center
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01680692
First received: August 29, 2012
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to evaluate whether a new regional anesthesia technique would provide better pain control, patient satisfaction, less narcotic use and no symptoms of foot drop after knee replacement surgery.


Condition Intervention Phase
Analgesia in Total Knee Arthroplasty
Drug: Ropivicaine
Device: Continuous Femoral Nerve Catheter
Device: Continuous Tibial Nerve Catheter
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study Comparing Continuous Femoral and Tibial Nerve Blocks vs. Continuous Femoral and Single Shot Sciatic Nerve Block in Total Knee Arthroplasties.

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Post-Operative Analgesia [ Time Frame: Patients pain score will be evaluated after surgery until discharge, an average of 3 to 4 days. ] [ Designated as safety issue: No ]
    Will measure pain using visual analog scale.


Secondary Outcome Measures:
  • Foot Drop [ Time Frame: Evaluated in the first 24, 48, 72 hours prior to discharge. ] [ Designated as safety issue: Yes ]
    Daily lower extremity neurological examination of the foot (specifically dorsiflexion.


Other Outcome Measures:
  • Patient Satisfaction [ Time Frame: Evaluated every 24, 48 and 72 hours prior to discharge. ] [ Designated as safety issue: No ]
    Patient satisfaction assessed using a daily numeric scale form (1-5 with 5 being most satisfied).

  • Opioid Consumption [ Time Frame: Evaluated every 24, 48, 72 hours prior to discharge. ] [ Designated as safety issue: No ]
    Compare the total consumption of opioid use in study patients compared to control patients.


Estimated Enrollment: 76
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuous femoral and single shot sciatic nerve block
Will receive a pre-operative continuous femoral catheter and a post-operative single shot sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine and 20mL (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which will be running Ropivicaine 0.2 at 10cc/hr.
Drug: Ropivicaine
Infusion of local anesthetic for post-operative analgesia.
Device: Continuous Femoral Nerve Catheter
Continuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively.
Other Name: Continous femoral nerve catheter infusion
Experimental: Continuous femoral and tibial peripheral nerve catheters
Patients will receive a pre-operative continuous femoral catheter and a post-operative continuous tibial catheter with an initial bolus of 30 mL 0.5% Ropivicaine (femoral) and 20mL 0.2% Ropivicaine (tibial), which will be followed by infusions post-operatively running at 10cc/hr.
Drug: Ropivicaine
Infusion of local anesthetic for post-operative analgesia.
Device: Continuous Femoral Nerve Catheter
Continuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively.
Other Name: Continous femoral nerve catheter infusion
Device: Continuous Tibial Nerve Catheter
Continuous infusion of local anesthetic delivered through a tibial nerve catheter post-operatively.
Other Name: Continuous tibial nerve catheter infusion

Detailed Description:

The aim of this study is to compare and measure the effects of Ropivicaine given through catheters located in the femoral and tibial nerves on indices of sensory blockade after total knee arthroplasties. This is a randomized, prospective study designed to address the primary research question: Does placing a continuous femoral & tibial catheter infusion lead to superior analgesia and patient satisfaction during the entire hospital stay? The secondary research question is: Will selectively placing a continuous tibial catheter decrease the episodes of transient foot drop to zero? Investigators know from own regional institutional practices that by performing a continuous femoral with a single shot sciatic nerve block provides adequate analgesia of the entire leg, but by post-operative day 2 patient's begin to experience pain with rehabilitation and rest in the posterior-lateral aspect of the knee and leg secondary to wearing off of the sciatic nerve block anesthetic. Also, it is known that by blocking the sciatic nerve proximal to its bifurcation may lead to episodes of transient foot drop due to common peroneal nerve blockage and irritation. It is hypothesized that placement of continuous catheters in the femoral and tibial nerves would provide better analgesia and lead to no episodes of foot drop as compared to the patients that receive continuous femoral and single shot sciatic blocks.

Currently at Texas Tech Health Science Center-El Paso and University Medical Center, about 95% of patient's undergoing total knee arthroplasty's (TKAs) receives a continuous femoral infusion and a single shot sciatic with an initial bolus of 30mL (femoral) and 20mL (sciatic) of Ropivicaine 0.5% and an infusion of Ropivicaine 0.2% at a rate of 10cc/hr (usually started post-op) for at least the first 48-72 hours post-operatively. For our study, Orthopedic clinic will provide a copy of the consent form to the subject so that they can review it, and if interested in participating in the study, the patient can then contact the Principal Investigator or Study Coordinator directly. After informed consent is obtained, patients will be randomized during that time using a numbering system enclosed in sealed envelopes. Group 1 will receive a pre-operative continuous femoral catheter and a post-operative single shot sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine and 20mL (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which will be running Ropivicaine 0.2 at 10cc/hr. Group 2 will receive a pre-operative continuous femoral catheter and a post-operative continuous tibial catheter with an initial bolus of 30 mL 0.5% Ropivicaine (femoral) and 20mL 0.2% Ropivicaine (tibial), which will be followed by infusions post-operatively running at the same rate and dosage as group 1. All nerve blocks performed will be placed using a nerve stimulator (with no twitches lower than 0.2mA) under ultrasound-guidance. Proper catheter placement will be confirmed by injecting 3mL of air and visualizing by ultrasound. Once confirmed, the bolus dose as mentioned earlier of either Ropivicaine 0.5% (femoral) or 0.2% (sciatic/tibial) will be injected. All TKA cases will be performed under general anesthesia with laryngeal mask airway. Considering the fact that by placing a selective continuous tibial catheter pre-operatively, we run the risk of the catheter being the surgical field during the case. For this reason, it was decided that placement after the procedure would be best. Therefore, the patient will be taken back to the block room post-operatively and a continuous tibial nerve catheter or single shot (depending on what group assigned) will be placed and bolused using the same technique as previously described. To detect a 30% reduction in the pain score from 3-4 to a 1-2 would be required for an observed post-operative pain control difference. In order to achieve a statistically significant result to detect the previously observed difference, a sample of 38 patients in each group (total of 76) would be required. Assuming a high consent rate and given the fact many TKA's it is projected that this study can be completed in approximately 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients (18-85 years old) undergoing elective total knee arthroplasty's
  • American Society of Anesthesiology Classification (ASA) 1, 2, or 3

Exclusion Criteria:

  • Patient refusal

    • Under 18
    • Pregnancy
    • Presence of neurological disease or existing parasthesia
    • Diabetes
    • Chronic drug use
    • Infection of leg
    • American Society of Anesthesiology Classification (ASA) 4-6 (unstable conditions)
    • History of allergy to local anesthetics or opioids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680692

Contacts
Contact: Claudia Lozano, MPH 9155456560 claudia.lozano@ttuhsc.edu

Locations
United States, Texas
University Medical Center of El Paso, Texas Tech University Health Sciences Center Recruiting
El Paso, Texas, United States, 79915
Sub-Investigator: John Zaki, MD         
Principal Investigator: Hana Teissler, MD         
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Hana Teissler, MD Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso
Principal Investigator: John Zaki, MD Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso
  More Information

Additional Information:
No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01680692     History of Changes
Other Study ID Numbers: E12094
Study First Received: August 29, 2012
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Analgesia TKA
Total knee arthroplasty
Continuous femoral catheter
Continuous tibial catheter
Single shot sciatic

ClinicalTrials.gov processed this record on April 23, 2014