Recruiting

Analgesia

Sponsor:

University of Manitoba

Code:

NCT00869037

Conditions

Analgesia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Periarticular Injection

CFNB + Posterior Capsular Injection

Study Details

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

Study ID

NCT00869037

Start date

Mar, 2009

Status verified date

Jan, 2010

Completion date

Feb, 2012

Anticipated

Primary completion date

Jul, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Periarticluar Multimodal Technique

active comparator: CFNB plus Posterior Capsular Injection

Interventions

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 + 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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Sanjay Aragola, MD FRCA

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

Marshall S Tenenbein, MD

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

Locations

Concordia Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2K 3S8

More Information

Sponsor

University of Manitoba

Last update posted

Mar 24, 2011

Last verified

Jan, 2010

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2011-03-24.