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Intraoperative Posterior Cruciate Ligament (Transcruciate) Injection After Total Knee Arthroplasty (TKA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345604
First Posted: May 2, 2011
Last Update Posted: November 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Saskatoon Health Region
Information provided by (Responsible Party):
Jacelyn Larson, University of Saskatchewan
  Purpose

his study is being done because total knee replacements can leave patients with considerable pain after surgery. Therefore, many studies have been done to find the best ways to control knee pain after the surgery. Currently, a popular approach is to use many different techniques to control the pain. This includes injecting freezing (local anesthetic) into the spinal column (spinal anesthetic), injecting freezing close to the nerves of the knee and using various kinds of medications (e.g. narcotics and anti-inflammatory medications). Studies have shown using this a combination of techniques can reduce pain and allow earlier discharge from the hospital. However, one downside to this approach is it does not usually control the pain in the back of the knee. One new technique has been used to try and overcome this. This technique is called a "posterior cruciate ligament block" or "PCL block". It involves injecting a drug into the back of the knee which will block the nerves in this area. Sometimes the investigators refer to this as "freezing".

The purpose of our study is to determine whether this "PCL Block" will improve pain after the total knee replacement surgery. The investigators will also determine whether this technique will improve movement in the knee and lessen narcotic usage after the surgery.


Condition Intervention Phase
Arthroplasty, Replacement, Knee Procedure: transcruciate injection of 20cc of normal saline Procedure: transcruciate injection of 20 cc of 0.5% Ropivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Posterior Knee Pain Following Total Knee Arthroplasty Using an Intraoperative Posterior Cruciate Ligament (Transcruciate) Injection

Resource links provided by NLM:


Further study details as provided by Jacelyn Larson, University of Saskatchewan:

Primary Outcome Measures:
  • Knee flexion [ Time Frame: up to one week postoperative ]

Secondary Outcome Measures:
  • Postoperative pain score [ Time Frame: in PACU , on ward (baseline), and post-op day 1 & 2 at 10am & 6pm ]
    Pain scores will be recorded at rest and on attempt of achieving a 90 degree passive flexion of the knee.

  • Total narcotic consumption [ Time Frame: up to 1 week postoperative ]

Enrollment: 50
Study Start Date: May 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline Procedure: transcruciate injection of 20cc of normal saline
Group 2 (control group) will receive a transcruciate injection of 20cc of normal saline through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively).
Active Comparator: Ropivicaine Procedure: transcruciate injection of 20 cc of 0.5% Ropivacaine
Group 1 (study group) will receive a transcruciate injection of 20 cc of 0.5% Ropivacaine through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists' (ASA) physical status classification (ASA) I and II patients undergoing unilateral total knee arthroplasty at Saskatoon City Hospital
  • Patients recruited from the practice of 4 orthopedic surgeons

Exclusion Criteria:

  • Inability to obtain informed consent
  • Simultaneous bilateral total knee arthroplasty or revision cases
  • Preexisting neurological deficits in the distribution of the femoral nerve or known diagnosis of peripheral neuropathy
  • Coagulopathies
  • Infection either systemically or at the needle insertion sites
  • Allergies to local anesthetics or opioids
  • Patients with a history of narcotic dependency or chronic pain
  • ASA III and IV
  • Body Mass Index (BMI) > 40
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345604


Locations
Canada, Saskatchewan
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada, S7K 5T6
Sponsors and Collaborators
University of Saskatchewan
Saskatoon Health Region
  More Information

Responsible Party: Jacelyn Larson, Faculty, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01345604     History of Changes
Other Study ID Numbers: PCL block
First Submitted: April 28, 2011
First Posted: May 2, 2011
Last Update Posted: November 15, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents