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Preoperative Nerve Block for Ankle Arthritis
Phase 2 & 3
Recruiting
Led By Timur JP Özelsel, MD, DESA
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing elective reconstructive foot and ankle surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative period
Awards & highlights
Study Summary
This trial is testing whether or not freezing the nerves in the foot and ankle region before surgery, as opposed to after, will reduce the amount of inhaled anesthetic given to the patient during surgery.
Who is the study for?
Adults over 18, scheduled for elective reconstructive foot and ankle surgery, who can consent to a nerve block are eligible. Excluded are those with local anesthetic allergies, bleeding disorders, severe obesity (BMI >35), significant other illnesses or conditions that make the anesthesia protocol risky, inability to consent, hemidiaphragm issues on the opposite side of surgery, or pre-existing nerve problems.Check my eligibility
What is being tested?
The study is testing if applying a nerve block before foot and ankle surgery reduces sevoflurane (an inhaled anesthetic) use during the procedure. Patients receive either real local anesthetic or sham dextrose through catheters placed by ultrasound guidance. The amount of sevoflurane used is then compared between these two groups.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from Ropivacaine such as pain or infection; systemic effects may include low blood pressure, nausea, tingling sensations or muscle weakness. Dextrose solution typically has minimal side effects when used as a placebo.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for elective foot or ankle surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 postoperative hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 postoperative hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Age-adjusted MAC of sevoflurane per hour
Secondary outcome measures
Opioids
Intraoperative Mean blood pressure
Intraoperative heart rate
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Pre-GAActive Control2 Interventions
10 mL of 1% ropivacaine injection before the start of surgery and 10 ml of 5% dextrose injection at the end of surgery through both the popliteal and the saphenous catheter
Group II: Post-GAPlacebo Group2 Interventions
10 mL of 5% dextrose injection before the start of surgery and 10 ml of 1% ropivacaine injection at the end of surgery through both the popliteal and the saphenous catheter
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,038 Total Patients Enrolled
Lora Pencheva, MDStudy DirectorUniversity of Alberta
2 Previous Clinical Trials
50 Total Patients Enrolled
Timur JP Özelsel, MD, DESAPrincipal InvestigatorUniversity of Alberta
2 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am eligible for nerve block in my leg.I have a blood clotting disorder.I am 18 years old or older.You are allergic to local anesthesia.I am able to understand and agree to the study's procedures.You have existing problems with your nervous system (brain, spinal cord, or nerves).I am scheduled for elective foot or ankle surgery.My opposite side to the surgery has a weak diaphragm.I cannot undergo anesthesia due to severe health issues or allergies.I am unable to give consent by myself.I have a bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-GA
- Group 2: Post-GA
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are currently signed up to participate in this research?
"The clinical trial is recruiting patients, as indicated by the listing on clinicaltrials.gov. This particular study was posted on 8/1/2019 and received its most recent edit on 5/23/2022. They are 100 patients needed from 1 location."
Answered by AI
Are we still able to sign people up for this research project?
"This is an active trial that is currently looking for participants, as per the clinicaltrials.gov listing. The listing was first posted on 8/1/2019 and has most recently been updated on 5/23/2022."
Answered by AI
What are some of the more common reasons that people take Pre-GA?
"Pre-GA is often used in order to administer anesthesia during surgical procedures. Additionally, this medication can be helpful for pain management during and after labour as well as postoperative discomfort."
Answered by AI
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