Analgesia After Total Knee Arthroplasty

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: Unknown
• Conditions: Analgesia
• Intervention / Treatment: Drug: Periarticular Injection; Drug: CFNB + Posterior Capsular Injection

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Static and dynamic pain scores until post-operative day 2 (POD 2)	9:00 and 15:30 daily for the first 2 postoperative days

Secondary Outcome Measures

Outcome Measure	Time Frame
Equivalent narcotic consumption until POD 2	9:00 and 15:30 daily until POD 2
Number of patients requiring Ketamine and ketamine dosage for intractable pain	9:00 and 15:30 daily until POD 2
Number of patients requiring Cryo-Cuff for intractable pain	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	9:00 and 15:30 daily until POD 2
Incidence of narcotic related side effects (nausea, vomiting, pruritis, euphoria, dysphoria, hallucination, respiratory depression)	9:00 and 15:30 daily until POD 2
Number of patients able to mobilize with or without a frame	POD 1-2
Maximum knee flexion (active/passive)	POD 1-2, at discharge, and at first follow-up visit
Hospital length of stay	Until Hospital discharge
Patient satisfaction scores	POD 0-2, at hospital discharge, and at first postoperative follow-up visit

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Sanjay Aragola, MD, FRCA, University of Manitoba; Principal Investigator: Marshall S Tenenbein, MD, University of Manitoba

Publications and helpful links

General Publications

• Aragola S, Arenson B, Tenenbein M, Bohm E, Jacobsohn E, Turgeon T. Prospective randomized trial of continuous femoral nerve block with posterior capsular injection versus periarticular injection for analgesia in primary total knee arthroplasty. Can J Surg. 2021 Apr 28;64(3):E265-E272. doi: 10.1503/cjs.020519.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: March 24, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (Estimate): March 25, 2009

Study Record Updates

• Last Update Posted (Estimate): March 24, 2011
• Last Update Submitted That Met QC Criteria: March 23, 2011
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Randomized controlled study; Post operative pain; Continuous Femoral Nerve Block; Posterior Capsular injection; Periarticular injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: B2008:123