Skip to main content
Clinical Trials/NCT00869037
NCT00869037
Unknown
Phase 4

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

University of Manitoba1 site in 1 country90 target enrollmentMarch 2009

Overview

Phase
Phase 4
Intervention
Periarticular Injection
Conditions
Analgesia
Sponsor
University of Manitoba
Enrollment
90
Locations
1
Primary Endpoint
Static and dynamic pain scores until post-operative day 2 (POD 2)
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
February 2012
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Arms & Interventions

Periarticluar Multimodal Technique

Intervention: Periarticular Injection

CFNB plus Posterior Capsular Injection

Intervention: CFNB + Posterior Capsular Injection

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials