Analgesia After Total Knee Arthroplasty

Official Title: “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.

Intervention(s) in this Clinical Trial

• 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.
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Periarticluar Multimodal Technique
• Active Comparator: CFNB plus Posterior Capsular Injection

Primary 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
    Safety Issue?: No

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Manitoba Other

Overall Clinical Trial Officials and Contacts

Sanjay Aragola, MD, FRCA Principal Investigator University of Manitoba  

Overall Contact: Sanjay Aragola, MD FRCA 1-204-6617198 saragola@sbgh.mb.ca

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00869037

Study ID Number: B2008:123

ClinicalTrials.gov Identifier: NCT00869037

Health Authority: Canada: Health Canada