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Compares treatment options for Breast Reconstruction
Official title Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
ClinicalTrials.gov ID: NCT07209436
What this study is testing
- What it's testing
- The broad aim of this study is to compare the effectiveness of paravertebral and pectoral blocks on pain and physical well-being of patients undergoing immediate implant-based breast reconstruction.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patient 18 years or older
- Scheduled for unilateral or bilateral immediate implant-based breast reconstruction
- Therapeutic or prophylactic indication
- Patient understands the study procedures and objectives and is willing to participate
- Patient willing to and capable of providing informed consent
You likely can't join if
- Delayed breast reconstruction
- Allergy or contraindication to local anesthetics (PVB or PECS blocks)
- History of radiation therapy
- Planned sedation or general anesthesia protocol variation
- Morbid obesity as defined as a BMI greater than 40 kg/m2
- Renal insufficiency
See the full eligibility criteria
- Adult patient 18 years or older
- Scheduled for unilateral or bilateral immediate implant-based breast reconstruction
- Therapeutic or prophylactic indication
- Patient understands the study procedures and objectives and is willing to participate
- Patient willing to and capable of providing informed consent
- Delayed breast reconstruction
- Allergy or contraindication to local anesthetics (PVB or PECS blocks)
- History of radiation therapy
- Planned sedation or general anesthesia protocol variation
- Morbid obesity as defined as a BMI greater than 40 kg/m2
- Renal insufficiency
- Chronic pain syndrome or central sensitization disorders (e.g., fibromyalgia, CRPS)
- Use of implanted pain devices or neuromodulators
- Pre-existing neurological deficits in the surgical field
- Current chronic opioid use (daily use within the 2 weeks before surgery and duration of use greater than 4 weeks)
- Use of any nerve medications in the past 6 months, including antiepileptic medications (gabapentin, carbamazepine)
- History of drug or alcohol abuse or habitual alcohol intake greater than two standard drinks per day (e.g., two beers, two glasses of wine, or two mixed drinks)
- Any comorbidity that results in moderate or severe functional limitation, inability to communicate with the investigators or hospital staff
- History of a psychiatric disorder which would interfere with the study procedure
- Incarceration
- Any issue that at the discretion of the investigator would contraindicate the subject's participation
- Inability to understand the procedures and objectives of the study
- Inability to or unwilling to provide informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, 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.