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

NCT01345604 | Completed Phase 4

• 1 other identifier: PCL block
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Knee flexion

  up to one week postoperative

Secondary Outcomes (2)

• Postoperative pain score

  in PACU , on ward (baseline), and post-op day 1 & 2 at 10am & 6pm

• Total narcotic consumption

  up to 1 week postoperative

Study Arms (2)

Saline

PLACEBO COMPARATOR

Procedure: transcruciate injection of 20cc of normal saline

Ropivicaine

ACTIVE COMPARATOR

Procedure: transcruciate injection of 20 cc of 0.5% Ropivacaine

Interventions

transcruciate injection of 20cc of normal saline PROCEDURE

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).

Saline

transcruciate injection of 20 cc of 0.5% Ropivacaine PROCEDURE

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).

Ropivicaine

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Saskatoon Health Region: collaborator

Study Sites (1)

Saskatoon City Hospital

Saskatoon, Saskatchewan, S7K 5T6, Canada

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 2, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

CA (1)