Analgesia After Total Knee Arthroplasty

Sponsor

University of Manitoba (Other)

Overall Status

Unknown status

CT.gov ID

NCT00869037

Collaborator

(none)

Enrollment

Location

Arms

35.1

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Drug: Periarticular Injection Drug: CFNB + Posterior Capsular Injection	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Anticipated Primary Completion Date :

Jul 1, 2011

Anticipated Study Completion Date :

Feb 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Concordia Hospital	Winnipeg	Manitoba	Canada	R2K 3S8

Sponsors and Collaborators

University of Manitoba

Investigators

Principal Investigator: Sanjay Aragola, MD, FRCA, University of Manitoba
Principal Investigator: Marshall S Tenenbein, MD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00869037

Other Study ID Numbers:

B2008:123

First Posted:

Mar 25, 2009

Last Update Posted:

Mar 24, 2011

Last Verified:

Jan 1, 2010

Keywords provided by , ,

Randomized controlled study

Total knee arthroplasty

Post operative pain

Continuous Femoral Nerve Block

Posterior Capsular injection

Periarticular injection

Additional relevant MeSH terms:

Agnosia

Study Results

No Results Posted as of Mar 24, 2011