Clinical trial NCT00869037: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Analgesia
Keywords: Randomized controlled study
Total knee arthroplasty
Post operative pain
Continuous Femoral Nerve Block
Posterior Capsular injection
Periarticular injection
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Static and dynamic pain scores until post-operative day 2 (POD 2)
timeFrame: 9:00 and 15:30 daily for the first 2 postoperative days
Secondary outcomes:
measure: Equivalent narcotic consumption until POD 2
timeFrame: 9:00 and 15:30 daily until POD 2
measure: Number of patients requiring Ketamine and ketamine dosage for intractable pain
timeFrame: 9:00 and 15:30 daily until POD 2
measure: Number of patients requiring Cryo-Cuff for intractable pain
timeFrame: 9:00 and 15:30 daily until POD 2
measure: Number of patients with pain scores in the mild (numerical rating scale 0-3), moderate (NRS 3-7) and severe (NRS 7-10) range
timeFrame: 9:00 and 15:30 daily until POD 2
measure: Incidence of narcotic related side effects (nausea, vomiting, pruritis, euphoria, dysphoria, hallucination, respiratory depression)
timeFrame: 9:00 and 15:30 daily until POD 2
measure: Number of patients able to mobilize with or without a frame
timeFrame: POD 1-2
measure: Maximum knee flexion (active/passive)
timeFrame: POD 1-2, at discharge, and at first follow-up visit
measure: Hospital length of stay
timeFrame: Until Hospital discharge
measure: Patient satisfaction scores
timeFrame: POD 0-2, at hospital discharge, and at first postoperative follow-up visit
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Concordia Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Sanjay Aragola, MD, FRCA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Marshall S Tenenbein, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.