Analgesia After Total Knee Arthroplasty

Phase 4

• Conditions: Analgesia
• Interventions: Drug: Periarticular Injection; Drug: CFNB + Posterior Capsular Injection

• Registration Number: NCT00869037
• Lead Sponsor: University of Manitoba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Status Verified: 2010-01
• Last Update Submitted: 2011-03-23
• Last Update Posted: 2011-03-24
• Primary Completion: 2011-07
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periarticluar Multimodal Technique	Periarticular Injection	-
CFNB plus Posterior Capsular Injection	CFNB + Posterior Capsular Injection	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of patients able to mobilize with or without a frame	POD 1-2
Hospital length of stay	Until Hospital discharge
Equivalent narcotic consumption 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	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 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
Maximum knee flexion (active/passive)	POD 1-2, at discharge, and at first follow-up visit
Patient satisfaction scores	POD 0-2, at hospital discharge, and at first postoperative follow-up visit

Trial Locations

Locations (1)

Concordia Hospital; 🇨🇦 Winnipeg, Manitoba, Canada