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Local Anesthetic

Pecs-2 block (single injection) for Breast Surgery

Phase 4

Waitlist Available

Led By Brian M Ilfeld, MD,MS

Research Sponsored by University of California, San Diego

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 from entering the operating room until recovery room discharge, assessed up to 24 hours

Awards & highlights

Study Summary

This trial is testing a new type of nerve block called the "Pecs-2" block to see if it is as effective as the older "paravertebral" block in providing postoperative pain relief following breast surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evening of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evening of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and evening of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cumulative Operating and Recovery Room Opioid Consumption

Recovery Room Numeric Rating Scale Pain Scores

Secondary outcome measures

Average pain measured using the Numeric Rating Scale pain score

Awakenings due to pain

Current pain measured using the Numeric Rating Scale pain score

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pecs-2Experimental Treatment1 Intervention

For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine.

Group II: ParavertebralActive Control1 Intervention

For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pecs-2 block (single injection)

2021

Completed Phase 4

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,121 Previous Clinical Trials

1,520,786 Total Patients Enrolled

2 Trials studying Breast Surgery

200 Patients Enrolled for Breast Surgery

Brian M Ilfeld, MD,MSPrincipal InvestigatorUCSD Medical Center

1 Previous Clinical Trials

Frequently Asked Questions

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

Has the FDA provided authorization for single-dose Pecs-2 block treatments?

"The Pecs-2 block (single injection) was given the maximum safety score of 3 because it has achieved Phase 4 trial status, meaning this therapy is officially sanctioned."

Answered by AI

Is this trial recruiting new participants?

"This research endeavour, first published on February 25th 2021 and revised December 5th 2022, is not currently accepting participants. Nevertheless, there are five other medical trials that are open to enrolment right now."

Answered by AI

Recent research and studies

Regional Anesthesia and Pain MedicineJournal

Pectoral Nerves I and II Blocks in Multimodal Analgesia for Breast Cancer Surgery

Bashandy, Ghada Mohammad Nabih, and Dina Nabil Abbas. 2015. “Pectoral Nerves I and II Blocks in Multimodal Analgesia for Breast Cancer Surgery”. Regional Anesthesia and Pain Medicine. BMJ. doi:10.1097/aap.0000000000000163.

clinicaltrials.govStudy

Pectoralis Block vs Paravertebral Nerve Blocks for Breast Surgery

Brian M. Ilfeld, MD, MS 2021. "Pectoralis Block vs Paravertebral Nerve Blocks for Breast Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04742309.