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Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two types of numbing shots: one near the spine and one near the chest muscles. It looks at pain and physical well-being in adults having breast reconstruction with implants right after breast removal.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Scheduled for breast reconstruction with implants on one or both sides right after breast removal.
  • Having surgery to treat or prevent disease.
  • Understand the study steps and goals and want to take part.
  • Able and willing to give informed consent, which means agreeing after learning about the study.

Who can't join

  • Having breast reconstruction later rather than right after breast removal; past radiation treatment; or a planned change to the study's sedation or anesthesia plan.
  • Allergy to the numbing drugs or another medical reason not to use them; body mass index (BMI) over 40; or kidneys that do not work well.
  • Long-term pain or a condition that makes the body extra sensitive to pain, such as fibromyalgia or complex regional pain syndrome (CRPS); an implanted pain-control or nerve-stimulation device; or existing nerve problems in the surgery area.
  • Daily opioid pain medicine use in the 2 weeks before surgery, with use lasting more than 4 weeks; or any nerve medicine in the past 6 months, including gabapentin or carbamazepine.
  • Past drug or alcohol abuse, or usually drinking more than two standard alcoholic drinks a day.
  • A health condition that moderately or severely limits daily activities; trouble communicating with study or hospital staff; or a mental health condition that would interfere with the study.
  • Being in jail or prison, or any other issue the study doctor believes makes participation unsuitable.
  • Unable to understand the study steps and goals, or unable or unwilling to give informed consent.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 Exclusion Criteria: * 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

Study sites (1)

MA