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Nerve Blocks for Breast Reconstruction

N/A
Recruiting
Led By Kathryn Isaac, MD MPH FRCSC
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be female, and at least 19 years old.
Patients must be ASA grade I or II.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trialcompares two methods of pain control before and after breast surgery to reduce acute and chronic pain, opioid use and side effects, improve quality of recovery, and shorten hospital stays.

Who is the study for?
This trial is for women over 19 years old undergoing mastectomy with immediate breast reconstruction using tissue expanders or implants. They should be in good health (ASA grade I or II) and not too far from the hospital. It's not for those under 50kg, BMI over 35, pregnant, having bilateral reconstructions at once, on anticoagulants, with bleeding disorders, infections at injection sites, allergies to study meds or poor overall health (ASA III/IV).Check my eligibility
What is being tested?
The trial tests pain management techniques in breast surgery recovery. It compares a Thoracic paravertebral block (TPVB) combined with Pecs II local anesthetic block against TPVB with a sham Pecs II saline block. The focus is on acute and chronic pain levels, opioid use and side effects, patient recovery quality reports and hospital stay duration.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site of the nerve blocks used for anesthesia during surgery which could lead to infection if proper care isn't taken post-operation. Opioid-related side effects might occur due to medication consumption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman and I am 19 years old or older.
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I am in good or mild systemic disease condition.
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I am having a full breast removal with immediate reconstruction using an implant or tissue expander.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average pain score in the 24-hour post-operative period assessed by the Numerical Rating Scale.
Rate of participant recruitment
Rate of participant retention
+1 more
Secondary outcome measures
Acute patient-reported pain scores assessed by the Numerical Rating Scale
Length of stay in hospital in hours
Number of participants requiring rescue opioid analgesics and anti-emetics.
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Local anesthetic TPVB + Local anesthetic Pecs blockExperimental Treatment2 Interventions
Patients will receive a thoracic paravertebral with pecs block, both with local anesthetic infiltrate.
Group II: Local anesthetic TPVB + Sham Pecs blockPlacebo Group2 Interventions
Patients will receive a thoracic paravertebral with local anesthetic infiltrate and a pecs block with saline infiltrate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pecs block
2020
N/A
~160
Thoracic paravertebral block
2020
Completed Phase 3
~810

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,467,088 Total Patients Enrolled
Kathryn Isaac, MD MPH FRCSCPrincipal InvestigatorUniversity of British Columbia

Media Library

Thoracic paravertebral block Clinical Trial Eligibility Overview. Trial Name: NCT04860843 — N/A
Plastic Surgery Research Study Groups: Local anesthetic TPVB + Local anesthetic Pecs block, Local anesthetic TPVB + Sham Pecs block
Plastic Surgery Clinical Trial 2023: Thoracic paravertebral block Highlights & Side Effects. Trial Name: NCT04860843 — N/A
Thoracic paravertebral block 2023 Treatment Timeline for Medical Study. Trial Name: NCT04860843 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently soliciting participants?

"As per the information on clinicaltrials.gov, recruitment is still underway for this trial, which was originally published on May 1st 2021 and had its most recent update November 8th 2022."

Answered by AI

What is the principal aim of this research?

"The primary aim of this clinical trial, which will span a 12 month duration, is to ascertain the retention rate of participants. Secondary objectives include gauging post-operative vomiting (quantified by episodes reported in PACU and at home), acute pain scores via Numerical Rating Scale assessments preoperatively, four times an hour during their stay in the Post Anesthesia Care Unit and Inpatient Unit until discharge, as well as 24 hours after surgery; finally measuring post-operative nausea with a numerical rating scale score where higher numbers indicate better outcomes."

Answered by AI

How many volunteers are joining the research project?

"Affirmative. According to information found on clinicaltrials.gov, this investigation is currently recruiting candidates and initially went live on May 1st 2021. The latest update was made on November 8th 2022 and the study seeks 30 participants from one medical facility."

Answered by AI

Who else is applying?

What site did they apply to?
Mount St Joseph Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I need breast implant revision and am looking for a way to achieve this. I am also happy to vacation in Vancouver during the necessary time frame.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Nerve Blocks in Alloplastic Breast Reconstruction
Kathryn Isaac 2021. "Nerve Blocks in Alloplastic Breast Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04860843.
~0 spots leftby May 2024
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