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Local Anesthetic
CI 0.2% ropivacaine for Postoperative Pain
Phase 4
Waitlist Available
Led By Ki Jinn Chin, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative 48 hours
Awards & highlights
Study Summary
This is a clinical study to investigate and compare a new programmed intermittent bolus (PIB) delivery method for continuous popliteal sciatic nerve block for pain relief in patients undergoing major ankle surgery compared with the current practice of continuous local anesthetic infusion (CI).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative 48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average numerical rating score (NRS) for pain
Secondary outcome measures
NRS for pain at rest and with movement at specified time points
Number of local anesthetic PCA boluses administered
Patient satisfaction, on a 0-10 NRS
+1 moreTrial Design
2Treatment groups
Active Control
Group I: CI 0.2% ropivacaineActive Control1 Intervention
Patients in Group Continuous Infusion (CI) will receive continuous infusion of 0.2% ropivacaine at 5 mL/hour; total 4-hourly consumption = 20 mL = 40 mg ropivacaine.
• All patients will be able to self-administer PCA boluses of 5 mL of ropivacaine 0.2% at intervals of 30 minutes as required.
2) Oral patient controlled analgesia (PCA) using oxycodone or hydromorphone. Patients under 70 years of age will receive either 10 mg of oxycodone or 2 mg of hydromorphone 2 hourly as needed, and patients 70 years of age or older will receive 5 mg of oxycodone or 1 mg of hydromorphone 2 hourly as needed.
3) Oral acetaminophen 1,000 mg 6 hourly.
Group II: PIB 0.2% ropivacaineActive Control1 Intervention
Patients in Group programmed intermittent boluses (PIB) will receive automated programmed intermittent boluses of 10 mL of ropivacaine 0.2% every 2 hours; total 4-hourly consumption = 20 mL = 40 mg ropivacaine.
• All patients will be able to self-administer PCA boluses of 5 mL of ropivacaine 0.2% at intervals of 30 minutes as required.
2) Oral patient controlled analgesia (PCA) using oxycodone or hydromorphone. Patients under 70 years of age will receive either 10 mg of oxycodone or 2 mg of hydromorphone 2 hourly as needed, and patients 70 years of age or older will receive 5 mg of oxycodone or 1 mg of hydromorphone 2 hourly as needed.
3) Oral acetaminophen 1,000 mg 6 hourly.
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,465 Previous Clinical Trials
483,629 Total Patients Enrolled
3 Trials studying Postoperative Pain
400 Patients Enrolled for Postoperative Pain
Ki Jinn Chin, MDPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
430 Total Patients Enrolled
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