Analgesia After Total Knee Arthroplasty

March 23, 2011 updated by: University of Manitoba

Analgesia After Total Knee Arthroplasty: Randomized Controlled Trial Comparing (a) Periarticular Multimodal Technique With (B) Continuous Femoral Nerve Block + Posterior Capsular Injection

The recovery from knee replacement surgery often involves a significant amount of pain. The best way to prevent/treat this pain is unknown. This study will compare two accepted methods of pain control in order to determine which is superior. The first method involves the injection of a solution containing multiple medications into the knee joint at the time of surgery. The second method involves the placement of a catheter adjacent to the femoral nerve which senses pain from the knee. This catheter is used to deliver local anesthetic which serves to block the transmission of pain signals from the nerve. The catheter will be left in place until 2 days after surgery. This method is combined with injection of local anesthetic in a particular area of the knee joint at the time of surgery. Patients will be followed until 2 days after surgery in order to determine which method is superior. We believe the second method will be deemed superior.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • Recruiting
        • Concordia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I, II, & III patients
  • Elective primary total knee arthroplasty
  • Spinal Anesthesia

Exclusion Criteria:

  • Patients refusing consent
  • Contraindications to regional anesthesia
  • Pre-existing neurological disease
  • Allergy/contraindication to drugs used in the study
  • Revision knee arthroplasty
  • Patients with chronic pain/on narcotics preoperatively
  • Pre-existing Rheumatoid Arthritis/Ankylosing Spondylitis
  • Alcohol or drug abuse
  • Psychiatric disorders
  • Inability to use the outcome assessment tools
  • Wheel chair or walker dependent for mobilization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Periarticluar Multimodal Technique
Drug: Periarticular Injection
A 20 ml bolus of saline will be given through the sham femoral nerve block catheter. Periarticular infiltration solution containing 400 mg Ropivicaine, 30 mg Ketorolac, 5 mg Epidural Grade Morphine, and 0.6 ml of 1:1000 Epinephrine will be made up to a volume of 100 ml with saline. Intra-op, 20 ml will be injected into the posterior capsule; 40 ml in the quadriceps mechanism, retinacular tissues, medial and lateral collateral ligaments; 40 ml in the skin and subcutaneous tissues. The sham catheter will be connected to a saline infusion running at 15 ml/hr until the morning of post-operative day 2.
Active Comparator: CFNB plus Posterior Capsular Injection
Drug: CFNB + Posterior Capsular Injection
A 20 ml bolus of 0.2% Ropivacaine will be given via a femoral nerve catheter. Periarticular infiltration will be performed intra-op. 20 ml of 1% Ropivacaine in the posterior capsule; 20 ml of normal saline in the quadriceps mechanism, retinacular tissues, medial and lateral collateral ligaments; 20 ml of normal saline for the skin and subcutaneous tissues. Postoperatively, the femoral catheter will be infused with 0.15% Ropivacaine running at 15 ml/hour until the morning of post-operative day 2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Static and dynamic pain scores until post-operative day 2 (POD 2)
Time Frame: 9:00 and 15:30 daily for the first 2 postoperative days
9:00 and 15:30 daily for the first 2 postoperative days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Equivalent narcotic consumption until POD 2
Time Frame: 9:00 and 15:30 daily until POD 2
9:00 and 15:30 daily until POD 2
Number of patients requiring Ketamine and ketamine dosage for intractable pain
Time Frame: 9:00 and 15:30 daily until POD 2
9:00 and 15:30 daily until POD 2
Number of patients requiring Cryo-Cuff for intractable pain
Time Frame: 9:00 and 15:30 daily until POD 2
9:00 and 15:30 daily until POD 2
Number of patients with pain scores in the mild (numerical rating scale 0-3), moderate (NRS 3-7) and severe (NRS 7-10) range
Time Frame: 9:00 and 15:30 daily until POD 2
9:00 and 15:30 daily until POD 2
Incidence of narcotic related side effects (nausea, vomiting, pruritis, euphoria, dysphoria, hallucination, respiratory depression)
Time Frame: 9:00 and 15:30 daily until POD 2
9:00 and 15:30 daily until POD 2
Number of patients able to mobilize with or without a frame
Time Frame: POD 1-2
POD 1-2
Maximum knee flexion (active/passive)
Time Frame: POD 1-2, at discharge, and at first follow-up visit
POD 1-2, at discharge, and at first follow-up visit
Hospital length of stay
Time Frame: Until Hospital discharge
Until Hospital discharge
Patient satisfaction scores
Time Frame: POD 0-2, at hospital discharge, and at first postoperative follow-up visit
POD 0-2, at hospital discharge, and at first postoperative follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sanjay Aragola, MD, FRCA, University of Manitoba
  • Principal Investigator: Marshall S Tenenbein, MD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2008:123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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