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Analgesia After Total Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00869037
First received: March 24, 2009
Last updated: March 23, 2011
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Analgesia
 Drug: Periarticular Injection
Drug: CFNB + Posterior Capsular Injection
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesia After Total Knee Arthroplasty: Randomized Controlled Trial Comparing (a) Periarticular Multimodal Technique With (B) Continuous Femoral Nerve Block + Posterior Capsular Injection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Equivalent narcotic consumption until POD 2 [ Time Frame: 9:00 and 15:30 daily until POD 2 ] [ Designated as safety issue: No ]
  • Number of patients requiring Ketamine and ketamine dosage for intractable pain [ Time Frame: 9:00 and 15:30 daily until POD 2 ] [ Designated as safety issue: No ]
  • Number of patients requiring Cryo-Cuff for intractable pain [ Time Frame: 9:00 and 15:30 daily until POD 2 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of patients able to mobilize with or without a frame [ Time Frame: POD 1-2 ] [ Designated as safety issue: No ]
  • Maximum knee flexion (active/passive) [ Time Frame: POD 1-2, at discharge, and at first follow-up visit ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: Until Hospital discharge ] [ Designated as safety issue: No ]
  • Patient satisfaction scores [ Time Frame: POD 0-2, at hospital discharge, and at first postoperative follow-up visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869037

Contacts
Contact: Sanjay Aragola, MD FRCA 1-204-6617198 saragola@sbgh.mb.ca
Contact: Marshall S Tenenbein, MD 1-204-996-7847 marshalltenenbein@hotmail.com

Locations
Canada, Manitoba
Concordia Hospital Recruiting
Winnipeg, Manitoba, Canada, R2K 3S8
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Sanjay Aragola, MD, FRCA University of Manitoba
Principal Investigator: Marshall S Tenenbein, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Sanjay Aragola, Department of Anesthesia, Concordia General Hospital, University of Manitoba
ClinicalTrials.gov Identifier: NCT00869037     History of Changes
Other Study ID Numbers: B2008:123
Study First Received: March 24, 2009
Last Updated: March 23, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Randomized controlled study
Total knee arthroplasty
Post operative pain
 Continuous Femoral Nerve Block
Posterior Capsular injection
Periarticular injection

ClinicalTrials.gov processed this record on May 19, 2013