Motor Sparing Block vs. Peri-Articular Catheters

NCT01503528 | Terminated Phase 4

• 2 other identifiers: 18448101754
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine if one anaesthetic modality, either motor sparing nerve block or peri-articular local infiltration anaesthesia with infusion, is superior in providing postoperative analgesia following total knee joint arthroplasty and if the efficacy of analgesia affects TKA outcomes. These outcomes include pain and function for a period of up to 3 months, narcotic consumption, and specific non-pain complications, including cardiac, respiratory, central nervous system, thromboembolism, infection, nausea and vomiting and urinary retention. Economic outcomes will also be examined, including length of hospital stay, direct health care costs and patient satisfaction.

Conditions

Knee Joint Arthritis; Knee Joint Arthroplasty

Keywords

arthroplasty; wound; catheter; local; anesthesia; infiltration; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Primary outcome - Perioperative pain

  Postoperative pain levels on a visual analogue scale will be recorded while the patient is an inpatient up to a maximum of 4 days post-discharge, and again at 2 weeks post-op.

  day of surgery to 2 weeks post-op

Secondary Outcomes (8)

• Readiness and True Discharge times

  in-patient period

• Postoperative mobility/function

  Measured on day of surgery to discharge day 4. Functional outcomes will be collected at 6 weeks and 3 months post-op using WOMAC and KSS scores

• Analgesia/Narcotic Consumption

  day of surgery to post-discharge day 4

• Complications

  day of surgery to 3 months post-op

• Nausea and Sedation symptoms

  day of surgery to post-discharge day 4

Study Arms (2)

Motor Sparing Nerve Block

ACTIVE COMPARATOR

Motor sparing knee block (60mL of 0.5% ropivacaine with 10 mg Morphine, 30 mg Ketorolac and 150 mcg of epinephrine as the initial bolus) initiated in the preoperative period in the block room as per the standard practice and continued until discharge. Spinal anesthetic with 15 mg of hyperbaric bupivacaine. Patients will be connected to an Ambit infusion pump in the postoperative period set to deliver ropivacaine 0.2% at a basal infusion rate of 7 mL/Hr with patient controlled boluses of 5mL every hour for breakthrough pain. Patients will be discharged home following removal of the anaesthetic catheter and fulfilling criteria for discharge.

Procedure: Motor Sparing Nerve Block

Peri-Articular Catheters

EXPERIMENTAL

3 peri-articular catheters inserted at the end of surgery followed by peri-articular infiltration with ropivacaine 0.2% and wound infusions will be continued until discharge using elastomeric devices. Spinal anesthetic with 15 mg of hyperbaric bupivacaine. Patients will be discharged home following removal of the anaesthetic catheter and fulfilling criteria for discharge.

Procedure: Peri-articular Catheters

Interventions

Motor Sparing Nerve Block PROCEDURE

Continuous Motor sparing knee block (60mL of 0.5% ropivacaine with 10 mg Morphine, 30 mg Ketorolac and 150 mcg of epinephrine as the initial bolus) initiated in the preoperative period in the block room as per the standard practice and continued until discharge. Patients will be connected to an Ambit infusion pump in the postoperative period set to deliver ropivacaine 0.2% at a basal infusion rate of 7 mL/Hr with patient controlled boluses of 5mL every hour for breakthrough pain.

Motor Sparing Nerve Block

Peri-articular Catheters PROCEDURE

3 peri-articular catheters inserted at the end of surgery followed by periarticular infiltration with ropivacaine 0.2% and wound infusions will be continued until discharge using elastomeric devices.

Peri-Articular Catheters

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ASA physical status 1-3, Ability to give informed consent, No contraindications to regional techniques, Ability to perform study related tests, Scheduled for primary unilateral total knee arthroplasty

You may not qualify if:

• Revision of arthroplasty, Allergy to local anesthetics and multimodal analgesic drugs, Contraindications to spinal anesthesia, Inability to perform study related procedures, Inability to give informed consent, Wheel chair bound, Pregnancy, Chronic renal failure, BMI \>45

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre University Hospital

London, Ontario, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• James Howard, FRCSC

  Associate Professor, London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a prospective randomized clinical trial. For safety and logistical reasons, it cannot be blinded. In the perioperative period multiple factors contribute to discharge readiness. The major impediments to early discharge include poor pain control, opioid related adverse events, surgical/ medical complications, inability to achieve physiotherapy end points and patient's unwillingness to be discharged. We want to compare head to head, two previously evaluated fast-track paradigms. We are not comparing just the analgesic technique alone. We are comparing the pathways where the analgesic regimes are a component and differ, keeping the common factors similar between the groups. If a technique does not allow early ambulation, patients cannot be ready for discharge and thus resource utilization will be affected.

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 4, 2012
• Study Start: October 16, 2017
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

CA (1)