Recruiting NCT07209436
Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paravertebral block (single injection), Pectoral block.
- Who it may be relevant to
- Registry conditions: Breast Reconstruction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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]
- Brief Pain Inventory (BPI) Scoring [Time frame: 12 Months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07209436 · 25-544