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Procedure
Thoracic Paravertebral Block Anesthesia for Breast Cancer Surgery (TPVB Trial)
N/A
Recruiting
Led By Ariane Clairoux, MD
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
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 intraoperative, about 30 minutes
Awards & highlights
TPVB Trial Summary
This trial will compare single-injection vs multiple injections of thoracic paravertebral block for anesthesia during breast cancer surgery. It may reduce post-op nausea, narcotic use and hospital stay, and improve patient satisfaction.
Who is the study for?
This trial is for adults over 18 with a BMI under 35, undergoing breast cancer surgery without axillary node dissection. It's not for those with severe heart or liver disease, kidney failure, allergies to specific anesthetics, pregnant women, or individuals unable to communicate with researchers.Check my eligibility
What is being tested?
The study tests if one injection of thoracic paravertebral block (TPVB) anesthesia is as effective as three injections for breast cancer surgery. Patients are randomly assigned to either the single-injection group or the multiple-injections group.See study design
What are the potential side effects?
Potential side effects include discomfort at the injection site, risk of infection, vaso-vagal reactions (like dizziness), and general discomfort due to the procedure's duration.
TPVB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative, about 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative, about 30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total perioperative fentanyl (mcg) consumption
Total perioperative ketamine (mg) consumption
Secondary outcome measures
Adverse events
Block failure rate requiring General Anesthesia (GA) to commence surgery
Conversion rate to General Anesthesia (GA)
+6 moreTPVB Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Thoracic paravertebral block single injectionExperimental Treatment1 Intervention
Patients will either be in the sitting or prone position for the block. The block will be performed with the ultrasound transducer in the sagittal position about 2.5 to 3 cm lateral to the spinous process using a caudal to cranial in-plane needle approach. The thoracic vertebral levels will be identified by finding the first rib under ultrasound guidance and counting down levels appropriately.
The needle (80 mm 22-gauge Pajunk) will be introduced in-plane in a caudal to cranial direction until it punctures the costotransverse ligament. Saline in 1 ml increments will be injected to confirm correct placement of the needle tip. Injection of saline or local anesthetics deep to the costotransverse ligament will lead to an anterior displacement of the parietal pleura.
For the single-injection technique, injection of 30 ml of ropivacaine 0.5% will be done at the T3-T4 paravertebral space after negative aspiration.
Group II: Thoracic paravertebral block multiple (3) injectionsActive Control1 Intervention
Patients will either be in the sitting or prone position for the block. The block will be performed with the ultrasound transducer in the sagittal position about 2.5 to 3 centimeters (cm) lateral to the spinous process using a caudal to cranial in-plane needle approach. The thoracic vertebral levels will be identified by finding the first rib under ultrasound guidance and counting down levels appropriately.
The needle (80 mm 22-gauge echogenic SonoPlex needle from Pajunk) will be introduced in-plane in a caudal to cranial direction until it punctures the costotransverse ligament. Saline in 1 ml increments will be injected to confirm correct placement of the needle tip. Injection of saline or local anesthetics deep to the costotransverse ligament will lead to an anterior displacement of the parietal pleura.
For the 3-level technique, injections will be done at the levels of T2-T3, T3-T4, and T4-T5 with 10 ml of ropivacaine 0.5% at each level.
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Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
70 Previous Clinical Trials
5,492 Total Patients Enrolled
1 Trials studying Breast Cancer
27 Patients Enrolled for Breast Cancer
Ariane Clairoux, MDPrincipal InvestigatorCiusss de L'Est de l'Île de Montréal
2 Previous Clinical Trials
148 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an infection where I would get injections.I have moderate to severe obstructive sleep apnea.I have chosen not to participate in this trial.My body weight is under 50 kg.I cannot communicate with the research team.My kidney function is very low.I have been using opioids daily for chronic pain for the last 3 months.I am over 18, have an ASA status of I-III, a BMI under 35, and am getting a mastectomy without lymph node removal.I have a serious heart condition.I am on blood thinners or have a bleeding disorder.I am under 18 years old.My liver is not working properly.
Research Study Groups:
This trial has the following groups:- Group 1: Thoracic paravertebral block multiple (3) injections
- Group 2: Thoracic paravertebral block single injection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is enrollment still open for this clinical trial?
"Affirmative. The clinicaltrials.gov database indicates that this medical experiment, which was initially published on November 4th 2022, is presently enlisting volunteers. Approximately 68 patients must be recruited from 1 different healthcare facility."
Answered by AI
How many participants are eligible for enrollment in this trial?
"Affirmative, the clinicaltrials.gov entry for this trial confirms it is currently enrolling participants. This research project was initially listed on November 4th 2022 and last modified on February 1st 2023. Sixty-eight patients are required to join from a single medical facility."
Answered by AI
Which results is this trial attempting to achieve?
"This trial aims to assess total amount of ketamine used during the intraoperative period, which is about 30 minutes. Secondary objectives include evaluating adverse effects such as hypotension and vagal reaction; pre-surgical block levels with an ice test after 20 minutes post-block; and postoperative pain at rest and on movement (VAS) in PACU or day surgery unit every 15 minutes until discharge."
Answered by AI
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