NCT07209436 · Amy Colwell
Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Paravertebral block (single injection)
Paravertebral block at preop
PROCEDURE
Pectoral block
Pectoral block at preop
Primary outcome measures
Patient-reported physical well-being and breast symptoms
Time frame: 12 Months
Patient-reported physical well-being and breast symptoms will be evaluated using the Breast Quality of Life Physical Well-Being and Breast Symptoms scales. Values are scores from 0 to 100, with higher scores indicating better satisfaction or quality of life for patients undergoing breast surgery, such as those with breast cancer. These scores are derived from patient-reported outcome measures across different domains like satisfaction with breasts, psychosocial well-being, physical well-being (chest and abdomen), and sexual well-being.
Brief Pain Inventory (BPI) Scoring
Time frame: 12 Months
The BPI is a self-report questionnaire that assesses pain intensity and interference. It consists of two parts: Pain Severity: Measures the intensity of pain using a 0-10 scale, where 0 is "no pain" and 10 is "worst possible pain." Pain Interference: Measures how much pain interferes with daily activities using a 0-10 scale for seven items (e.g., general activity, mood, sleep). Calculation of Scores: Pain Severity Score: Add up the scores for the four pain severity questions (worst pain, least pain, average pain, current pain) and divide by 4. Pain Interference Score: Add up the scores for the seven pain interference questions and divide by 7. Interpretation: Pain Severity: 0-3: Mild pain 4-6: Moderate pain 7-10: Severe pain Pain Interference: Higher scores indicate greater interference with daily activities.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 22, 2026 · Source of record for eligibility and locations