NCT01680692

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

August 29, 2012

Last Update Submit

April 23, 2018

Conditions

Analgesia in Total Knee Arthroplasty

Keywords

Analgesia TKATotal knee arthroplastyContinuous femoral catheterContinuous tibial catheterSingle shot sciatic

Outcome Measures

Primary Outcomes (1)

  • Post-Operative Analgesia

    Will measure pain using visual analog scale.

    Patients pain score will be evaluated after surgery until discharge, an average of 3 to 4 days.

Secondary Outcomes (1)

  • Foot Drop

    Evaluated in the first 24, 48, 72 hours prior to discharge.

Other Outcomes (2)

  • Patient Satisfaction

    Evaluated every 24, 48 and 72 hours prior to discharge.

  • Opioid Consumption

    Evaluated every 24, 48, 72 hours prior to discharge.

Study Arms (2)

Continuous femoral and single shot sciatic nerve block

ACTIVE COMPARATOR

Will receive pre-operative continuous femoral catheter \& post-operative single shot sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine \& 20mL (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which will be running Ropivicaine 0.2 at 10cc/hr.

Drug: RopivicaineDevice: Continuous Femoral Nerve Catheter

Continuous femoral and tibial peripheral nerve catheters

EXPERIMENTAL

Patients will receive pre-operative continuous femoral catheter \& post-operative continuous tibial catheter with an initial bolus of 30 mL 0.5% Ropivicaine (femoral) \& 20mL 0.2% Ropivicaine (tibial), which will be followed by infusions post-operatively running at 10cc/hr.

Drug: RopivicaineDevice: Continuous Femoral Nerve CatheterDevice: Continuous Tibial Nerve Catheter

Interventions

RopivicaineDRUG

Infusion of local anesthetic for post-operative analgesia.

Continuous femoral and single shot sciatic nerve blockContinuous femoral and tibial peripheral nerve catheters
Continuous Femoral Nerve CatheterDEVICE

Continuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively.

Also known as: Continous femoral nerve catheter infusion
Continuous femoral and single shot sciatic nerve blockContinuous femoral and tibial peripheral nerve catheters
Continuous Tibial Nerve CatheterDEVICE

Continuous infusion of local anesthetic delivered through a tibial nerve catheter post-operatively.

Also known as: Continuous tibial nerve catheter infusion
Continuous femoral and tibial peripheral nerve catheters

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center of El Paso, Texas Tech University Health Sciences Center

El Paso, Texas, 79915, United States

Location

Related Links

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 7, 2012

Study Start

August 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations

US(1)