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Bupivicaine HCl for Revision Surgery

Phase 4
Recruiting
Led By Judith Aronsohn, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ASA I-III.
Undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up4 to 10 hours
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Study Summary

This trial is testing whether a serratus plane block can reduce postoperative pain and opioid use in people undergoing breast surgery, compared to placebo.

Eligible Conditions
  • Revision Surgery
  • Outpatient Breast Surgery
  • Breast Lift
  • Augmentation

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 to 10 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 to 10 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative opioid requirements
Secondary outcome measures
Incidence of antiemetic use
Incidence of postoperative nausea and vomiting
PACU length of stay
+2 more

Side effects data

From 2018 Phase 2 trial • 285 Patients • NCT03015532
70%
Nausea
40%
Constipation
35%
Vomiting
25%
Dizziness
20%
Tachycardia
20%
Hyperhidrosis
20%
Anaemia postoperative
15%
Headache
15%
Muscle spasms
15%
Dry mouth
10%
Pain
10%
Oedema peripheral
10%
Pruritus
10%
Pruritus generalised
10%
Hypokalaemia
10%
Hypertension
5%
Lethargy
5%
Hyponatraemia
5%
Arthralgia
5%
Postoperative fever
5%
Wound drainage
5%
Dysphagia
5%
Thrombocytosis
5%
Erythema
5%
Sinus tachycardia
5%
Joint swelling
5%
Leukocytosis
5%
Feeling cold
5%
Chills
5%
Hyperkalaemia
5%
Pyrexia
5%
Inflammation
5%
Retching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2, Group 3: Saline Placebo
Cohort 1, Group 1: HTX-011
Cohort 1, Group 2: HTX-011
Cohort 1, Group 3: Saline Placebo
Cohort 2, Group 1: HTX-011
Cohort 2, Group 2: HTX-011 + Ropivacaine
Cohort 2, Group 4: Bupivacaine HCI
Cohort 1, Group 4: Bupivacaine HCI

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bupivicaine HClExperimental Treatment1 Intervention
Ultrasound guided serratus plane block with bupivacaine HCl.
Group II: Normal SalinePlacebo Group1 Intervention
Placebo injection on operated side, same technique as experimental group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivicaine HCl
2017
Completed Phase 2
~570

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
449 Previous Clinical Trials
468,275 Total Patients Enrolled
Judith Aronsohn, MDPrincipal Investigator - Northwell Health
Northwell Health
1 Previous Clinical Trials
58 Total Patients Enrolled

Frequently Asked Questions

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

Is Bupivicaine HCl a reliable and secure form of treatment?

"The safety of Bupivicaine HCl was assigned a rating of 3 on the 1-3 scale due to this being a Phase 4 trial, signifying that it has been approved."

Answered by AI

What criteria must be met for individuals to qualify for this research project?

"The clinical trial requires 90 candidates with ages ranging from 18 to 75. To qualify, individuals must fulfil the American Society of Anesthesiologists (ASA) I-III criteria and be undergoing outpatient breast surgery requiring general anaesthesia such as mastectomy, lumpectomy or revisional reconstruction operations involving tissue expanders/implants."

Answered by AI

Do you accept participants under the age of 25 for this research?

"The parameters for this clinical trial necessitate that potential participants must have surpassed the age of majority and be under 75 years old."

Answered by AI

What is the present sample size for this experiment?

"Affirmative. According to the details found on clinicaltrials.gov, this medical experiment is still in search of participants and was published on September 5th 2017 with its most recent update being November 17 2021. Ninety individuals are needed for enrollment across a single centre."

Answered by AI

Are individuals being accepted to participate in this experiment at present?

"Evidenced on clinicaltrials.gov, this investigation is actively seeking qualified volunteers. This experiment was opened to the public on September 5th 2017 and its data was most recently updated on November 17th 2021."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Serratus Plane Block for Postoperative Pain Control
Judith Aronsohn, MD 2017. "Serratus Plane Block for Postoperative Pain Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02865928.
~13 spots leftby Nov 2024
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