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Trial NCT07209436

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

Phase
Not given
Sponsor
Amy Colwell
Conditions
Breast Reconstruction
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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/m2BMI * Renal insufficiencyRenal * 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

Restrictions found (2)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County