Analgesia After Total Knee Arthroplasty - Full Text View

Sponsored by:	University of Manitoba
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00869037

Purpose

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	Intervention	Phase
Analgesia	Drug: Periarticular Injection Drug: CFNB + Posterior Capsular Injection	Phase IV

MedlinePlus related topics: Knee Replacement Nausea and Vomiting Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Analgesia After Total Knee Arthroplasty: Randomized Controlled Trial Comparing (a) Periarticular Multimodal Technique With (B) Continuous Femoral Nerve Block + Posterior Capsular Injection

Further study details as provided by University of Manitoba:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Equivalent narcotic consumption until POD 2 [ Time Frame: 9:00 and 15:30 daily until POD 2 ] [ Designated as safety issue: No ]
Number of patients requiring Ketamine and ketamine dosage for intractable pain [ Time Frame: 9:00 and 15:30 daily until POD 2 ] [ Designated as safety issue: No ]
Number of patients requiring Cryo-Cuff for intractable pain [ Time Frame: 9:00 and 15:30 daily until POD 2 ] [ Designated as safety issue: No ]
Number of patients with pain scores in the mild (numerical rating scale 0-3), moderate (NRS 3-7) and severe (NRS 7-10) range [ Time Frame: 9:00 and 15:30 daily until POD 2 ] [ Designated as safety issue: No ]
Incidence of narcotic related side effects (nausea, vomiting, pruritis, euphoria, dysphoria, hallucination, respiratory depression) [ Time Frame: 9:00 and 15:30 daily until POD 2 ] [ Designated as safety issue: No ]
Number of patients able to mobilize with or without a frame [ Time Frame: POD 1-2 ] [ Designated as safety issue: No ]
Maximum knee flexion (active/passive) [ Time Frame: POD 1-2, at discharge, and at first follow-up visit ] [ Designated as safety issue: No ]
Hospital length of stay [ Time Frame: Until Hospital discharge ] [ Designated as safety issue: No ]
Patient satisfaction scores [ Time Frame: POD 0-2, at hospital discharge, and at first postoperative follow-up visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Periarticluar Multimodal Technique: Active Comparator	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 plus Posterior Capsular Injection: Active Comparator	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

Arms

Assigned Interventions

Periarticluar Multimodal Technique: Active Comparator

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 plus Posterior Capsular Injection: Active Comparator

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Wheel chair or walker dependent for mobilization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869037

Contacts

Contact: Sanjay Aragola, MD FRCA	1-204-6617198	saragola@sbgh.mb.ca
Contact: Marshall S Tenenbein, MD	1-204-996-7847	marshalltenenbein@hotmail.com

Locations

Canada, Manitoba
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

More Information

No publications provided

Responsible Party:	Department of Anesthesia, Concordia General Hospital, University of Manitoba ( Sanjay Aragola )
Study ID Numbers:	B2008:123
Study First Received:	March 24, 2009
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00869037 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of Manitoba:

Randomized controlled study
Total knee arthroplasty
Post operative pain

Continuous Femoral Nerve Block
Posterior Capsular injection
Periarticular injection

Study placed in the following topic categories:

Morphine
Ropivacaine
Ketorolac
Pain

Epinephrine
Ketorolac Tromethamine
Pain, Postoperative

ClinicalTrials.gov processed this record on May 07, 2009