Thoracic paravertebral block single injection for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
CIUSSS de l'Est de l'Île de Montréal, Montréal, CanadaBreast Cancer+2 MoreThoracic paravertebral block single injection - Procedure
Eligibility
18+
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Intraoperative, about 30 minutes

Hour 3
Adverse events
Intraoperative, about 30 minutes
Block failure rate requiring General Anesthesia (GA) to commence surgery
Conversion rate to General Anesthesia (GA)
Level of the block using ice test preoperatively
Total dose of propofol (mg) required for sedation
Total perioperative fentanyl (mcg) consumption
Total perioperative ketamine (mg) consumption
Postoperative, about 2 hours
PONV (Post Operative Nausea and Vomiting) in PACU and day surgery unit
Postoperative pain at rest and on movement (VAS) in PACU and day surgery unit
Postoperative total analgesic dose of hydromorphone (mg)
Readiness for hospital discharge (following regular institution criteria)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Thoracic paravertebral block multiple (3) injections
1 of 2
Thoracic paravertebral block single injection
1 of 2

Active Control

Experimental Treatment

68 Total Participants · 2 Treatment Groups

Primary Treatment: Thoracic paravertebral block single injection · No Placebo Group · N/A

Thoracic paravertebral block single injection
Procedure
Experimental Group · 1 Intervention: Thoracic paravertebral block single injection · Intervention Types: Procedure
Thoracic paravertebral block multiple (3) injections
Procedure
ActiveComparator Group · 1 Intervention: Thoracic paravertebral block multiple (3) injections · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: intraoperative, about 30 minutes

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
60 Previous Clinical Trials
4,329 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

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.