Analgesia After Total Knee Arthroplasty

NCT00869037 | Unknown Phase 4

• 1 other identifier: B2008:123
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Keywords

Randomized controlled study; Total knee arthroplasty; Post operative pain; Continuous Femoral Nerve Block; Posterior Capsular injection; Periarticular injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Periarticluar Multimodal Technique

ACTIVE COMPARATOR

Drug: Periarticular Injection

CFNB plus Posterior Capsular Injection

ACTIVE COMPARATOR

Drug: CFNB + Posterior Capsular Injection

Interventions

Periarticular Injection DRUG

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.

Periarticluar Multimodal Technique

CFNB + Posterior Capsular Injection DRUG

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

CFNB plus Posterior Capsular Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I, II, \& III patients
• Elective primary total knee arthroplasty
• Spinal Anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 33908425 DERIVED

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Sanjay Aragola, MD, FRCA

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Marshall S Tenenbein, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjay Aragola, MD FRCA

CONTACT

1-204-6617198; saragola@sbgh.mb.ca

Marshall S Tenenbein, MD

CONTACT

1-204-996-7847; marshalltenenbein@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: February 1, 2012
• Last Updated: March 24, 2011

Record last verified: 2010-01

Locations

CA (1)