Recruiting PHASE4 Macromastia (Symptomatic)

New treatment option for Macromastia (Symptomatic)

Official title Pectoral Block in Breast Reduction for Pain Control

ClinicalTrials.gov ID: NCT07527039

What this study is testing

What is Post Operative Pain Relievers?

Post Operative Pain Relievers is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for macromastia (symptomatic).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
A reduction mammoplasty is a commonly performed procedure for patients with symptomatic macromastia. The procedure involves removing breast parenchyma for an overall reduction in breast size and to alleviate patient symptoms, such as back/neck pain, rashes in the inframammary fold, and bra strap indentation.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75, women only

You may be able to join if

  • Undergoing breast reduction surgery
  • Women older than age 18 and under age 75
  • Stable breast size for at least 1 year
  • Member has persistent symptoms in at least two of the anatomical body areas below, directly attributed to macromastia and affecting daily activities...
  • Patient has evidence of severe breast hypertrophy that is documented by frontal and side profile photographs

You likely can't join if

  • History of chronic pain controlled with prescribed narcotics
  • English as non-primary language
  • No access to email or internet
  • Positive pre-surgery pregnancy test
  • Women not of ages 18-75
  • Less than 40 kg in weight
See the full eligibility criteria
Who can join
  • Undergoing breast reduction surgery
  • Women older than age 18 and under age 75
  • Stable breast size for at least 1 year
  • Member has persistent symptoms in at least two of the anatomical body areas below, directly attributed to macromastia and affecting daily activities for at least 1 year: Headaches; Pain in neck; Pain in shoulders; Pain...
  • Patient has evidence of severe breast hypertrophy that is documented by frontal and side profile photographs
  • Pain symptoms persist as documented by the physician despite at least a 3-month trial of therapeutic measures such as: Analgesic/non-steroidal anti-inflammatory drugs (NSAIDs) interventions and/or muscle relaxants...
  • Breast Reduction is likely to cause a reduction in patient symptoms
  • Women 50 years of age or older are required to have a mammogram that was negative for cancer performed within the two years prior to the date of the planned reduction mammoplasty
  • Greater than 40 kg in weight
What rules you out
  • History of chronic pain controlled with prescribed narcotics
  • English as non-primary language
  • No access to email or internet
  • Positive pre-surgery pregnancy test
  • Women not of ages 18-75
  • Less than 40 kg in weight

The study team makes the final eligibility decision.

Where it's taking place

  • Roanoke, Virginia, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Roanoke, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.