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Completed

NCT Number: NCT01345604

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

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.

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Key information

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saskatoon City Hospital

Saskatoon, Saskatchewan, S7K 5T6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. Knee flexion

    Time frame: up to one week postoperative

Secondary outcomes

  1. 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.

  2. Total narcotic consumption

    Time frame: up to 1 week postoperative

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Saskatoon Health Region

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 2, 2011
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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