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Bupivicaine HCl for Outpatient Breast Surgery

Phase 4

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 30 minutes in the pacu for the first four hours and at hourly intervals up until pacu discharge, up to 10 hours.

Awards & highlights

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

Breast Lift
Outpatient Breast Surgery
Revision Surgery
Augmentation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 30 minutes in the pacu for the first four hours and at hourly intervals up until pacu discharge, up to 10 hours.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 30 minutes in the pacu for the first four hours and at hourly intervals up until pacu discharge, up to 10 hours.

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 30 minutes in the pacu for the first four hours and at hourly intervals up until pacu discharge, up 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

Number of Participants Who Required Antiemetics During the Postoperative Period.

PACU Length of Stay

Patient Experience and Satisfaction With a 5-point Categorial Scale

+2 more

Side effects data

From 2018 Phase 2 trial • 285 Patients • NCT03015532

70%

Nausea

40%

Constipation

35%

Vomiting

25%

Dizziness

20%

Hyperhidrosis

20%

Tachycardia

20%

Anaemia postoperative

15%

Headache

15%

Muscle spasms

15%

Dry mouth

10%

Hypokalaemia

10%

Pruritus

10%

Pruritus generalised

10%

Oedema peripheral

10%

Pain

10%

Hypertension

Arthralgia

Dysphagia

Thrombocytosis

Postoperative fever

Hyponatraemia

Leukocytosis

Lethargy

Erythema

Feeling cold

Pyrexia

Sinus tachycardia

Wound drainage

Joint swelling

Chills

Hyperkalaemia

Inflammation

Retching

100%

80%

60%

40%

20%

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

458 Previous Clinical Trials

470,891 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.