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

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Reducing Posterior Knee Pain Following Total Knee Arthroplasty Using an Intraoperative Posterior Cruciate Ligament (Transcruciate) Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345604
• Other study ID #: PCL block
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2011
• Last updated: November 10, 2016
• Start date: May 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2016
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 100 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

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).
• 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).

Locations

Country	Name	City	State
Canada	Saskatoon City Hospital	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Saskatoon Health Region

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee flexion		up to one week postoperative	No
Secondary	Postoperative pain score	Pain scores will be recorded at rest and on attempt of achieving a 90 degree passive flexion of the knee.	in PACU , on ward (baseline), and post-op day 1 & 2 at 10am & 6pm	No
Secondary	Total narcotic consumption		up to 1 week postoperative	No