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Local Anesthetic

Pain Relief Methods for Post-Knee Surgery Pain

Phase 3

Waitlist Available

Led By Sugantha Ganapathy, FRCPC

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Good contralateral leg strength

Male and females of 18-85 years of age, scheduled to undergo elective primary total knee arthroplasty

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 18 postoperative hours

Awards & highlights

Study Summary

This trial will compare two methods of pain relief after knee replacement surgery, to see if one is more effective than the other.

Who is the study for?

This trial is for men and women aged 18-85 who are scheduled for elective primary total knee replacement surgery, have good strength in their other leg, and are generally healthy (ASA Class I-III). It's not suitable for those with severe systemic disease (ASA Class IV+), psychiatric illnesses, drug allergies relevant to the study, or conditions that prevent informed consent.Check my eligibility

What is being tested?

The study compares two pain management techniques after knee replacement: a motor sparing knee block administered before surgery using ultrasound versus local anesthetic infiltration by surgeons post-surgery. The effect of adding dexmedetomidine to prolong pain relief will also be evaluated.See study design

What are the potential side effects?

Possible side effects include reactions to Ropivacaine such as nerve damage or low blood pressure; epinephrine can cause palpitations; Dexmedetomidine may lead to dry mouth or low heart rate; morphine might induce nausea; Ketorolac could result in stomach issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My other leg is strong.

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I am between 18 and 85 years old and scheduled for a first-time knee replacement.

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My health is good to moderately impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 18 postoperative hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 18 postoperative hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 18 postoperative hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of analgesia

Secondary outcome measures

discharge criteria

pain scores at rest

pain scores on movement

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Motor free with DexExperimental Treatment6 Interventions

Patients in group 3 will receive motor sparing knee blocks with 0.5% ropivacaine with 1 µg/Kg of dexmedetomidine, 30 mg of ketorolac and 10 mg of morphine with a total local anesthetic volume of 60 ml (300 mg). Patients in group 3 will receive sham injections of saline (100 ml) periarticularly at the end of surgery.

Group II: Motor freeExperimental Treatment6 Interventions

Patients in group 2 will receive motor sparing knee blocks with 0.5% ropivacaine with 2.5 µg/mL of epinephrine, 30 mg of ketorolac and 10 mg of morphine with a total local anesthetic volume of 60 ml (300 mg). Sham injections of saline (100 ml) will be injected periarticularly at the end of surgery.

Group III: PeriarticularActive Control6 Interventions

Patients in group 1 will receive periarticular infiltration of LA mixture (100 ml) consisting of 0.3% ropivacaine, 2.5 µg/mL of epinephrine, 10 mg of morphine and 30 mg of ketorolac at the end of surgery and sham injections of saline into the motor sparing knee blocks preoperatively.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ropivacaine

FDA approved

Epinephrine

FDA approved

Dexmedetomidine

FDA approved

Morphine

FDA approved

Ketorolac

FDA approved

saline

2011

Completed Phase 4

~1480

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

663 Previous Clinical Trials

413,895 Total Patients Enrolled

21 Trials studying Osteoarthritis

5,432 Patients Enrolled for Osteoarthritis

Sugantha Ganapathy, FRCPCPrincipal InvestigatorLHSC, UWO, Canada

2 Previous Clinical Trials

125 Total Patients Enrolled

Media Library

Motor free (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT02540070 — Phase 3

Osteoarthritis Research Study Groups: Motor free, Periarticular, Motor free with Dex

Osteoarthritis Clinical Trial 2023: Motor free Highlights & Side Effects. Trial Name: NCT02540070 — Phase 3

Motor free (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02540070 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of pain does Ropivacaine typically alleviate?

"Ropivacaine can help patients that are experiencing unresponsive bradycardia, pupil, and labour."

Answered by AI

Are individuals over the age of 40 welcome in this research project?

"The age range of patients who can enroll in this trial is 18 to 85 years old. There are 103 clinical trials that involve patients under 18 and 852 for senior citizens."

Answered by AI

What other research studies have used Ropivacaine as a trial medication?

"There are 63 phase 3 trials and 295 active trials in total for Ropivacaine. The majority of these are located in Boston, MA, but there are a total of 512 medical centres running these sorts of studies."

Answered by AI

Are there specific inclusion or exclusion criteria for this trial?

"This research is looking for 135 individuals, aged 18 to 85, who have been diagnosed with arthrosis. Additionally, participants must have good contralateral leg strength."

Answered by AI

Are there any patients that this research trial is still seeking?

"This clinical trial has completed recruitment for participants. The study was first posted on 8/1/2014 and was most recently updated on 11/11/2016. There are 693 other trials currently searching for participants with arthrosis and 295 studies for Ropivacaine actively admitting patients."

Answered by AI

Could you inform me as to how many individuals are participating in this clinical trial?

"Currently, this study is not enrolling new patients. Although, this study was last updated on November 11th, 2016, it is not presently looking for candidates. However, there are 693 clinical trials for patients with arthrosis and 295 trials for Ropivacaine that are actively recruiting."

Answered by AI