Analgesia After Total Knee Arthroplasty

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00869037
• Other study ID #: B2008:123
• Status: Recruiting
• Phase: Phase 4
• First received: March 24, 2009
• Last updated: March 23, 2011
• Start date: March 2009
• Est. completion date: February 2012

Study information

• Verified date: January 2010
• Source: University of Manitoba
• Contact: Sanjay Aragola, MD FRCA
• Phone: 1-204-6617198
• Email: saragola[@]sbgh.mb.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	Concordia Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static and dynamic pain scores until post-operative day 2 (POD 2)		9:00 and 15:30 daily for the first 2 postoperative days	No
Secondary	Equivalent narcotic consumption until POD 2		9:00 and 15:30 daily until POD 2	No
Secondary	Number of patients requiring Ketamine and ketamine dosage for intractable pain		9:00 and 15:30 daily until POD 2	No
Secondary	Number of patients requiring Cryo-Cuff for intractable pain		9:00 and 15:30 daily until POD 2	No
Secondary	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	No
Secondary	Incidence of narcotic related side effects (nausea, vomiting, pruritis, euphoria, dysphoria, hallucination, respiratory depression)		9:00 and 15:30 daily until POD 2	No
Secondary	Number of patients able to mobilize with or without a frame		POD 1-2	No
Secondary	Maximum knee flexion (active/passive)		POD 1-2, at discharge, and at first follow-up visit	No
Secondary	Hospital length of stay		Until Hospital discharge	No
Secondary	Patient satisfaction scores		POD 0-2, at hospital discharge, and at first postoperative follow-up visit	No