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Ropivacaine injection for Post-Surgical Pain
N/A
Waitlist Available
Led By Peter Moisiuk, MD
Research Sponsored by McMaster University
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 48 hours
Awards & highlights
Study Summary
This trial will look at the feasibility of using a fascial plane block to control pain in patients undergoing laparoscopic nephrectomy for cancer, as well as investigate total opioid consumption and pain scores.
Eligible Conditions
- Post-Surgical Pain
- Kidney Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1-2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1-2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility - Enrollment rate of greater than one patient per week with 100% in-hospital follow-up
Secondary outcome measures
Number of Adverse Events
Opioid Consumption
Pain scores at rest and movement
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ultrasound-guided continuous ESP block with opioid PCAExperimental Treatment1 Intervention
A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T7/T8 spinous process. The patient's skin will be anesthetized with 2% lidocaine. A Contiplex Echo ultra 360 18G needle with 20G × 55 cm Contiplex Echo catheter will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.375% ropivacaine with 5mcg/mL of epinephrine will be injected in 5-mL aliquots through the needle (maximum of 3mg/kg) followed by insertion of the echo catheter system under direct vision 2-3 cm beyond the needle tip.
Group II: Ultrasound-guided sham block and catheter with opioid PCAPlacebo Group1 Intervention
The exact same procedure as the experimental group will be followed, substituting saline for local anesthetic at the same amounts and rate. As with the ESP group, the patients will have PCA initiated postoperatively in the PACU at the same doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
FDA approved
Find a Location
Who is running the clinical trial?
St. Joseph's Healthcare HamiltonOTHER
196 Previous Clinical Trials
25,534 Total Patients Enrolled
McMaster UniversityLead Sponsor
880 Previous Clinical Trials
2,597,818 Total Patients Enrolled
Peter Moisiuk, MDPrincipal InvestigatorSt. Joseph's Healthcare Hamilton and McMaster University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot receive paravertebral blocks if you have an infection at the needle insertion site, empyema, allergy to local anesthetic drugs, a tumor in the thoracic paravertebral space or if you have a bleeding disorder, coagulopathy, or are taking blood thinning medication.You need laparoscopic surgery to remove a cancerous kidney or part of a kidney.You are allergic to local anesthetics.You have cystic kidney and have undergone a surgery in which a very large incision was made.You have long-lasting pain conditions.If you have had a kidney removed for donation, you cannot participate if the incision was made in a specific location.You do not want to participate in the study.You have been taking opioid medication for at least three months before the surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Ultrasound-guided continuous ESP block with opioid PCA
- Group 2: Ultrasound-guided sham block and catheter with opioid PCA
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Are there vacancies available to participants at this research endeavor?
"According to the info posted on clinicaltrials.gov, recruitment for this trial is still ongoing. The study was initially made public on April 1st 2020 and its details were last revised November 8th 2022."
Answered by AI
How many volunteers are participating in this scientific experiment?
"Right. According to clinicaltrials.gov, this investigation is presently recruiting participants; the trial's announcement was made on April 1st 2020 and changed for the final time on November 8th 2022. The study needs 22 patients from a single location."
Answered by AI
What medical conditions is Ropivacaine injection typically prescribed to address?
"Ropivacaine injection is the standard treatment for anesthesia procedures, yet it has been proven to relieve other types of pain including surgical-related discomfort and even labour pains."
Answered by AI
Are there other investigations related to the injection of Ropivacaine?
"Currently, 67 clinical trials related to Ropivacaine injection are underway and 15 of those studies have reached their third phase. Karachi, Sindh is the most popular location for this research; nevertheless 89 locations worldwide host trials involving Ropivacaine injections."
Answered by AI
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