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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Saskatoon Health Region
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01345604
First received: April 28, 2011
Last updated: June 15, 2012
Last verified: June 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Saskatchewan:

Primary Outcome Measures:
  • Knee flexion [ Time Frame: up to one week postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative pain score [ Time Frame: in PACU , on ward (baseline), and post-op day 1 & 2 at 10am & 6pm ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345604

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

No publications provided

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01345604     History of Changes
Other Study ID Numbers: PCL block
Study First Received: April 28, 2011
Last Updated: June 15, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on August 28, 2014