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Analgesia After Total Knee Arthroplasty

Primary Purpose

Analgesia

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Periarticular Injection
CFNB + Posterior Capsular Injection
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring Randomized controlled study, Total knee arthroplasty, Post operative pain, Continuous Femoral Nerve Block, Posterior Capsular injection, Periarticular injection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Concordia HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Periarticluar Multimodal Technique

CFNB plus Posterior Capsular Injection

Arm Description

Outcomes

Primary Outcome Measures

Static and dynamic pain scores until post-operative day 2 (POD 2)

Secondary Outcome Measures

Equivalent narcotic consumption until POD 2
Number of patients requiring Ketamine and ketamine dosage for intractable pain
Number of patients requiring Cryo-Cuff for intractable pain
Number of patients with pain scores in the mild (numerical rating scale 0-3), moderate (NRS 3-7) and severe (NRS 7-10) range
Incidence of narcotic related side effects (nausea, vomiting, pruritis, euphoria, dysphoria, hallucination, respiratory depression)
Number of patients able to mobilize with or without a frame
Maximum knee flexion (active/passive)
Hospital length of stay
Patient satisfaction scores

Full Information

First Posted
March 24, 2009
Last Updated
March 23, 2011
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT00869037
Brief Title
Analgesia After Total Knee Arthroplasty
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 Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
Randomized controlled study, Total knee arthroplasty, Post operative pain, Continuous Femoral Nerve Block, Posterior Capsular injection, Periarticular injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Periarticluar Multimodal Technique
Arm Type
Active Comparator
Arm Title
CFNB plus Posterior Capsular Injection
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Periarticular Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CFNB + Posterior Capsular Injection
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Equivalent narcotic consumption until POD 2
Time Frame
9:00 and 15:30 daily until POD 2
Title
Number of patients requiring Ketamine and ketamine dosage for intractable pain
Time Frame
9:00 and 15:30 daily until POD 2
Title
Number of patients requiring Cryo-Cuff for intractable pain
Time Frame
9:00 and 15:30 daily until POD 2
Title
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
Title
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
Title
Number of patients able to mobilize with or without a frame
Time Frame
POD 1-2
Title
Maximum knee flexion (active/passive)
Time Frame
POD 1-2, at discharge, and at first follow-up visit
Title
Hospital length of stay
Time Frame
Until Hospital discharge
Title
Patient satisfaction scores
Time Frame
POD 0-2, at hospital discharge, and at first postoperative follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 Wheel chair or walker dependent for mobilization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjay Aragola, MD FRCA
Phone
1-204-6617198
Email
saragola@sbgh.mb.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marshall S Tenenbein, MD
Phone
1-204-996-7847
Email
marshalltenenbein@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Aragola, MD, FRCA
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marshall S Tenenbein, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concordia Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 3S8
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
33908425
Citation
Aragola S, Arenson B, Tenenbein M, Bohm E, Jacobsohn E, Turgeon T. Prospective randomized trial of continuous femoral nerve block with posterior capsular injection versus periarticular injection for analgesia in primary total knee arthroplasty. Can J Surg. 2021 Apr 28;64(3):E265-E272. doi: 10.1503/cjs.020519.
Results Reference
derived

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Analgesia After Total Knee Arthroplasty

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