80 Participants NeededMy employer runs this trial

Pectoral Block for Pain Control in Breast Reduction

PD
Overseen ByPatrick Dugom, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Carilion Clinic
Must be taking: Analgesics, NSAIDs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for managing pain after breast reduction surgery. It tests whether the PEC II block, a type of nerve block, can match the effectiveness of the usual narcotic-based method while causing fewer side effects. This approach could reduce issues such as nausea and dependency associated with narcotics. Women experiencing symptoms from large breasts, like neck or shoulder pain, and considering breast reduction surgery might be suitable for this trial. Participants should have experienced these symptoms affecting daily life for at least a year. As a Phase 4 trial, the research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have tried other pain management methods like NSAIDs or muscle relaxants for at least 3 months before surgery.

What is the safety track record for the Pectoral II Nerve Block treatment?

Studies have shown that the Pectoral II nerve block offers promising results for controlling pain after breast surgery. Research indicates it can significantly reduce pain following breast reduction surgery and decrease the need for opioid painkillers. This is important because opioids often cause side effects like nausea and carry a risk of addiction.

The Pectoral II block involves injecting a numbing medicine into a specific area of the chest. Multiple studies have found this method to be generally safe and effective, with no serious side effects reported. Patients who received the Pectoral II block experienced less pain and used fewer opioids compared to those who did not receive the block.

Overall, the Pectoral II nerve block appears well-tolerated, making it a good option for managing pain after breast reduction surgery.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Pectoral II nerve block for pain control in breast reduction surgeries because it offers a new approach to managing postoperative pain. Unlike the traditional method where a wetting solution with lidocaine and epinephrine is used, the Pectoral II block utilizes a combination of 0.25% bupivacaine with epinephrine, dexmedetomidine, and dexamethasone. This combination aims to provide targeted pain relief directly to the nerves, potentially reducing the need for narcotics and enhancing recovery. By focusing on nerve blocks, this method could offer more effective pain control with fewer side effects compared to standard options.

What evidence suggests that the Pectoral II Nerve Block is effective for pain control in breast reduction?

This trial will compare the effectiveness of the PECS II block with a control group for pain management in breast reduction surgery. Research has shown that the PECS II block can significantly reduce pain after breast surgery. Studies have found that patients receiving this block report less pain and require fewer pain medications post-surgery. For instance, one study found that the PECS II block provided much better pain relief compared to not using it. Another study highlighted that it reduces the need for opioids, which are strong painkillers often associated with side effects. Overall, the PECS II block appears to offer effective pain control for breast surgeries.16789

Who Is on the Research Team?

AC

Anthony Capito, MD

Principal Investigator

Carilion Clinic

Are You a Good Fit for This Trial?

This trial is for women aged 18–75 with very large breasts causing symptoms like back, neck, or shoulder pain who are scheduled for breast reduction surgery. Participants must have stable breast size for at least a year and meet certain health requirements, including recent mammograms if over age 50.

Inclusion Criteria

I am having breast reduction surgery.
I am a woman between 18 and 74 years old.
* Stable breast size for at least 1 year
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo breast reduction surgery with either PECs II block or standard multimodal pain control

1 day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for pain control and narcotic usage through surveys on days 1, 3, and 7 post-surgery

1 week
Surveys on days 1, 3, and 7

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pectoral II Nerve Block

Trial Overview

The study compares two ways to manage pain after breast reduction: one group gets a nerve block (Pectoral II Block) alone, while the other receives standard pain control that includes narcotic medications. The goal is to see if the nerve block works as well as traditional methods.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: PEC II block groupExperimental Treatment2 Interventions
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials
85
Recruited
15,400+

Citations

Comparison of the Effects of Pectoral Nerve Block and Local ...

... Pecs II block significantly reduced postoperative pain after breast reduction surgery. It was also observed that intraoperative and postoperative analgesic ...

Efficacy of PECS block in addition to multimodal analgesia for ...

Pectoralis nerve blocks (PECS) have been shown in numerous studies to be a safe and effective method to treat postoperative pain and reduce postoperative opioid ...

The efficacy of pectoral nerve block for pain control after .. ...

Compared with control group after breast augmentation, pectoral nerve block was associated with substantially reduced pain scores at 1 hour ( ...

Efficacy of pectoralis nerve blocks I & II with liposomal ...

The purpose of this study was to evaluate the effect of performing PECs blocks with LB for patients undergoing breast reduction procedures. The primary outcome ...

PECS II block is associated with lower incidence of chronic ...

This block can provide good anesthesia for the breast and axilla region; however, it is usually unable to cover the parasternal branches of the ...

Evaluation of the Efficacy of Pectoral Nerve-2 Block (PECS ...

This study aimed to evaluate the efficacy of the pectoral nerves interfacial plane block (PECS II) in breast cancer surgery focusing on postoperative pain ...

Pectoral Block in Breast Reduction for Pain Control

The Pectoral II block is a modified Pectoral I block and can be achieved using a single needle stick. Local anesthetic placement is between the pectoralis major ...

PECS II block is associated with lower incidence of chronic ...

In conclusion, our study suggests that the PECS II block could be able to prevent chronic pain after breast surgery at 3 months after surgery.

Efficacy of PECS block in addition to multimodal analgesia ...

Pectoralis nerve blocks (PECS) have been shown in numerous studies to be a safe and effective method to treat postoperative pain and reduce postoperative opioid ...